Company ยท US
Antibodies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1989. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 1 |
| DNJ | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 1989 | K890774 | GIARDEIA(TM) Antibodies, Inc. | KHW |
| Oct 30, 1984 | K843590 | DETECT-A-STREP Antibodies, Inc. | GTZ |
| Nov 1, 1982 | K822892 | CORTISOL RIA KIT Antibodies, Inc. | CGR |
| Oct 19, 1981 | K812749 | ULTRA-DIG Antibodies, Inc. | LCS |
| Sep 1, 1981 | K812314 | CRITHIDNA ANTI-DNA TEST KIT Antibodies, Inc. | DHN |
| Dec 19, 1980 | K802877 | AMIKACIN RIA KIT Antibodies, Inc. | KLQ |
| Apr 16, 1980 | K800743 | TOBRAMYCIN RIA KIT Antibodies, Inc. | KLB |
| Sep 4, 1979 | K791217 | TSH RIA KIT Antibodies, Inc. | JLW |
| Nov 8, 1978 | K781656 | NEPHELRATE ANTISERUMS, IGG Antibodies, Inc. | CFN |
| Nov 8, 1978 | K781655 | NEPHELRATE ANTISERUMS 1GA Antibodies, Inc. | CFN |
| Nov 8, 1978 | K781654 | NEPHELRATE ANTIPERUMS LGM Antibodies, Inc. | CFN |
| Nov 8, 1978 | K781653 | NEPHELRATE ANTISERUMS C3C Antibodies, Inc. | CZW |
| Apr 28, 1978 | K780516 | GENTAMICIN RIA KIT Antibodies, Inc. | DJB |
| Nov 17, 1977 | K772122 | T3 RIA KIT Antibodies, Inc. | CDP |
| Oct 21, 1977 | K771877 | DIGOXIN RIA KIT Antibodies, Inc. | DNJ |
| Sep 13, 1977 | K771585 | T3 UPTAKE DIAG. KIT Antibodies, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||