Company ยท US
Monoclonal Antibodies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1988. 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 |
|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 1988 | K874863 | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) Monoclonal Antibodies, Inc. | GQN |
| Jul 27, 1987 | K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) Monoclonal Antibodies, Inc. | CEP |
| Nov 5, 1986 | K863744 | HCG CONTROL KIT Monoclonal Antibodies, Inc. | JJX |
| Jul 2, 1986 | K860924 | RAMP PROGESTURINE PDG ASSAY--48 TEST KIT Monoclonal Antibodies, Inc. | JLS |
| Dec 30, 1985 | K854611 | RAMP URINE HCG ASSAY Monoclonal Antibodies, Inc. | JHI |
| Apr 2, 1985 | K850730 | MODEL SERUM HCG ASSAY Monoclonal Antibodies, Inc. | JHI |
| Mar 5, 1985 | K850480 | OVU STICK SELF-TEST -MODIFICATION Monoclonal Antibodies, Inc. | CEP |
| Dec 11, 1984 | K843284 | OVUSTICK SELF-TEST Monoclonal Antibodies, Inc. | CEP |
| Apr 19, 1984 | K840738 | PLUS URINE HCG ASSAY Monoclonal Antibodies, Inc. | JHJ |
| Apr 13, 1984 | K840412 | OVU STICK URINE HLH KIT Monoclonal Antibodies, Inc. | CEP |
| Jan 9, 1984 | K833504 | PREGNASTICK URINE HCG KIT Monoclonal Antibodies, Inc. | JHJ |
| Sep 12, 1983 | K832562 | SERUM HCG ASSAY Monoclonal Antibodies, Inc. | JHI |
| Jun 2, 1983 | K831155 | B-CLONE HCG ASSAY Monoclonal Antibodies, Inc. | JHJ |
| Sep 28, 1982 | K822520 | MODEL UCG ASSAY Monoclonal Antibodies, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||