# Schiapparelli Biosystems, Inc.

- Location (FDA's records): Fairfield, NJ
- FDA decisions: 24 (1993–1999): 24 510(k) clearances
- Product codes: DIP (2), KLS (1), DLZ (1), KLT (1), DLJ (1), JGY (1), MRR (1), JGJ (1), JIX (1), KHQ (1), DJD (1), JJE (1)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 40 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Reagents, Inc.: 8 (https://510kreport.com/company/diagnostic-reagents)
- Genzyme Corp.: 2 (https://510kreport.com/company/genzyme)

## Firms that cite its devices most
- Alfa Wassermann Diagnostic Technologies, Inc.: 29 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)
- Alfa Wassermann, Inc.: 9 (https://510kreport.com/company/alfa-wassermann)
- Alfa Wassermann Diagnostics Technologies, LLC: 2 (https://510kreport.com/company/alfa-wassermann-diagnostics-technologies)

## Its most-cited devices
- K931786: Ace Clinical Chemistry  System (1993), cited by 22
- K930104: Ace Clinical Chemistry System (1993), cited by 7
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls (1999), cited by 3
- K944911: Ace Iron Reagent (1995), cited by 2
- K981377: Ace T4 Reagent T4 Calibrators (1998), cited by 2
- K971526: Ace HDL-C Reagent (1997), cited by 2

## Recent decisions
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls (Jul 13, 1999)
- K981375: Ace T Uptake Reagent TU Calibrators (Jun 10, 1998)
- K981377: Ace T4 Reagent T4 Calibrators (Jun 10, 1998)
- K973583: Ace Theophylline Reagent, Theo Calibrators (Nov 12, 1997)
- K973582: Ace Primidone Reagent, Aed Calibrators (Nov 12, 1997)
- K973581: Ace Valproic Acid Reagent, Aed Calibrators (Nov 12, 1997)
- K973536: Ace Phenobarbital Reagent/Aed Calibrators (Nov 6, 1997)
- K973414: Ace Phenytoin Reagent, Aed Calibrators (Nov 4, 1997)

Source page: https://510kreport.com/company/schiapparelli-biosystems