Company ยท US
Princeton Biomedix
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1995. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJR | Acid Phosphatase, Thymol Blue Monophosphate | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 1995 | K942052 | LIFESIGN MI MYOGLOBIN Princeton Biomedix | DDR |
| Jul 12, 1994 | K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST Princeton Biomedix | LFX |
| Mar 4, 1993 | K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP Princeton Biomedix | CEP |
| Feb 23, 1993 | K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST Princeton Biomedix | KTN |
| Jan 26, 1993 | K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST Princeton Biomedix | LCX |
| May 4, 1990 | K901011 | BIOSIGN HCG-ONE STEP PREGNANCY TEST Princeton Biomedix | JHI |
| Oct 18, 1989 | K894750 | BIOSTIX I. HCG - ONE STEP PREGNANCY TEST Princeton Biomedix | JHI |
| Oct 18, 1989 | K894705 | BIOSPOT HCG-RAPID PREGNANCY TEST Princeton Biomedix | JHI |
| Jun 19, 1989 | K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST Princeton Biomedix | DHA |
| Feb 24, 1977 | K761315 | ALKALINE PHOSPHATASE (ALP)/PNPP Princeton Biomedix | CJE |
| Oct 27, 1976 | K760346 | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE Princeton Biomedix | JPZ |
| Oct 27, 1976 | K760345 | TEST, LACTATE DEHYDROGENASE Princeton Biomedix | CFJ |
| Oct 5, 1976 | K760347 | SET, TRINDER GLUCOSE Princeton Biomedix | CGA |
| Jul 20, 1976 | K760161 | TEST, ACID PHOSPHATASE Princeton Biomedix | CJR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||