# Kallestad Laboratories, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 92 (1976–1986): 92 510(k) clearances
- Product codes: DGC (8), DHB (5), DEH (4), CZP (3), DFT (3), JZS (3), CZQ (2), DEW (2), DCK (2), DCE (2), LIQ (2), DFH (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Bio-Rad: 13 (https://510kreport.com/company/bio-rad)

## Its most-cited devices
- K792610: Kallestad Florescent Ana/Ama/Asma Test (1980), cited by 7
- K813592: Quantafluor Fluorescent Test Reagents (1982), cited by 4
- K780899: Fluorescent Anti-Native Dna Test (1978), cited by 2

## Recent decisions
- K863681: Pathfinder (TM) Direct Antigen Detection System (Dec 3, 1986)
- K862917: Pathfinder Rotavirus Chemiluminescent (Oct 22, 1986)
- K863682: Pathfinder (TM) Specimen Collection Kit (Oct 10, 1986)
- K862743: Pathfinder (TM) Respiratory Syncytial Virus (Sep 29, 1986)
- K862313: Kallestad SM/RNP Test Reagent (Aug 6, 1986)
- K862710: Kallestad Ssa/SSB Ena Test Reagents (Jul 29, 1986)
- K855014: Quantimetric Plus Calibrator/Control Set a (Mar 14, 1986)
- K855010: Quantimetric Plus Igm Reagent Kit (Feb 28, 1986)

Source page: https://510kreport.com/company/kallestad-laboratories