# Isolab, Inc.

- Location (FDA's records): Akron, OH
- FDA decisions: 44 (1977–1996): 44 510(k) clearances
- Product codes: LCP (7), JCM (4), GHM (4), DFT (2), JBD (2), LGL (2), CIN (1), JPC (1), KHO (1), JJX (1), GKA (1), MLL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Perkinelmer, Inc.: 1 (https://510kreport.com/company/perkinelmer)

## Its most-cited devices
- K840011: Resolve-HB (1984), cited by 1
- K950803: Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample (1995), cited by 1

## Recent decisions
- K951014: Isolab's T4 Test Kit (Oct 18, 1996)
- K950481: Neonatal Chemistry System, Galactose Test Kit (Feb 1, 1996)
- K943547: Phenylalanine Test Kit (Jan 26, 1996)
- K950803: Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample (Sep 21, 1995)
- K950415: Fluoroscan Neonatal (Sep 5, 1995)
- K942276: Quik-Sep Quantitative Hemoglobin S Assay (Jan 20, 1995)
- K942222: Quik-Sep Quantitive Hemoglobin S Controls (Jan 20, 1995)
- K944185: Isoscan (Nov 17, 1994)

Source page: https://510kreport.com/company/isolab