# Caltag Laboratories, Inc.

- Location (FDA's records): South San Francisco, CA
- FDA decisions: 12 (1995–1999): 12 510(k) clearances
- Product codes: GKZ (11), GHQ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (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
- Sure-Tech Diagnostic Associates, Inc.: 1 (https://510kreport.com/company/sure-tech-diagnostic-associates)

## Recent decisions
- K990641: Caltag Fetal Hemoglobin Test (Sep 17, 1999)
- K965232: Caltag Cal-Lyse (May 14, 1997)
- K964856: CD3 Fitc/CD19 R-PE/CD45 Tri-Color Monoclonal Antibody Combination (Jan 17, 1997)
- K963954: CD 19 R-PE, CD19 Tri-Color Monoclonal Antibody (Nov 25, 1996)
- K950916: CD3 Fitc/CD8 R-PE Monoclonal Antibody Combination (Dec 21, 1995)
- K951073: CD3 Tri-Color/CD4 R-PE/CD8 Fitc Monoclonal Antibody Combination (Dec 21, 1995)
- K950918: CD3 Fitc/CD4 R-PE Monoclonal Antibody Combination (Dec 21, 1995)
- K950917: CD3 Fitc/CD8 R-PE/CD45 Tri-Color Monoclonal Antibody Combination (Dec 21, 1995)

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