Company ยท US
Caltag Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1999. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 1999 | K990641 | CALTAG FETAL HEMOGLOBIN TEST Caltag Laboratories, Inc. | GHQ |
| May 14, 1997 | K965232 | CALTAG CAL-LYSE Caltag Laboratories, Inc. | GKZ |
| Jan 17, 1997 | K964856 | CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Nov 25, 1996 | K963954 | CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950918 | CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950917 | CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 21, 1995 | K950916 | CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Dec 20, 1995 | K950919 | CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. | GKZ |
| Jun 20, 1995 | K944128 | CALTAG CD4 R-PE MONOCLONAL ANTIBODY Caltag Laboratories, Inc. | GKZ |
| Jun 20, 1995 | K944127 | CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY Caltag Laboratories, Inc. | GKZ |
| Jun 20, 1995 | K944126 | CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES Caltag Laboratories, Inc. | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||