# Instrumentation Laboratory CO

- Location (FDA's records): Lexington, MA
- FDA decisions: 327 (1976–2023): 326 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Instrumentation Laboratory CO (321); Instrumentation Laboratory (3); Instrumentation Laboratory Company (3)
- Product codes: GGP (28), CHL (16), JPA (12), GJS (11), GJT (10), DAP (10), GKP (9), CGA (9), JBQ (9), GGN (8), KFF (6), JXR (5)
- 510(k) review time since 2016: median 251 days, against 249 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 210 (154 its own); citations of its devices by later devices: 202 (154 its own)
- Recalls linked to its devices: 98 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Diagnostic Technologies, Inc.: 9 (https://510kreport.com/company/medical-diagnostic-technologies)
- Biokit USA, Inc.: 5 (https://510kreport.com/company/biokit-usa)
- Kabivitrum, Inc.: 5 (https://510kreport.com/company/kabivitrum)
- bioMerieux, Inc.: 3 (https://510kreport.com/company/biomerieux)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Corgenix, Inc.: 2 (https://510kreport.com/company/corgenix)
- Ortho Diagnostic Systems, Inc.: 2 (https://510kreport.com/company/ortho-diagnostic-systems)
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)

## Firms that cite its devices most
- Sekisui Medical Co., Ltd.: 5 (https://510kreport.com/company/sekisui-medical)
- Avl Scientific Corp.: 4 (https://510kreport.com/company/avl-scientific)
- Instrumentation Laboratory (IL) Co.: 4 (https://510kreport.com/company/instrumentation-laboratory-il)
- Precision Biologic: 4 (https://510kreport.com/company/precision-biologic)
- Vital Scientific N.V.: 3 (https://510kreport.com/company/vital-scientific)
- Siemens Healthcare Diagnostics Products GmbH: 3 (https://510kreport.com/company/siemens-healthcare-diagnostics-products)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Biokit, S.A.: 2 (https://510kreport.com/company/biokit)

## Its most-cited devices
- K002400: Modification of Acl Advance (2000), cited by 14
- K133407: Gem Premier 4000 (2014), cited by 7
- K823480: IL 943 Flame Photometer (1983), cited by 6
- K972696: IL Test D-Dimer (1997), cited by 5
- K073377: Acl Top (with System Software V3.0.0) (2008), cited by 4
- K980499: IL Test Antithrombin (1998), cited by 4

## Recent decisions
- K233790: Acl Top 970 CL (Dec 29, 2023)
- K230852: HemosIL Chromogenic Factor IX (Dec 13, 2023)
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (Sep 29, 2023)
- K223608: GEM Premier 7000 with IQM3 (Aug 10, 2023)
- K223187: HemosIL Liquid Anti-Xa (Jun 23, 2023)
- K231031: ACL TOP Family 70 Series (Jun 21, 2023)
- K223090: GEM Premier ChemSTAT (Jan 27, 2023)
- K223402: HemosIL von Willebrand Factor Antigen (Dec 9, 2022)

Source page: https://510kreport.com/company/instrumentation-laboratory