Company ยท US
Microscan Div. Baxter Healthcare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1987. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 3 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 1 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 1 |
| KIR | Cells, Animal And Human, Cultured | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 1987 | K871234 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 Microscan Div. Baxter Healthcare Corp. | GQS |
| Jun 26, 1987 | K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A Microscan Div. Baxter Healthcare Corp. | GNX |
| Jun 26, 1987 | K871232 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 Microscan Div. Baxter Healthcare Corp. | GQS |
| Jun 26, 1987 | K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B Microscan Div. Baxter Healthcare Corp. | GNX |
| Jun 26, 1987 | K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS Microscan Div. Baxter Healthcare Corp. | LKT |
| Jun 26, 1987 | K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL Microscan Div. Baxter Healthcare Corp. | GOD |
| Jun 26, 1987 | K871228 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 Microscan Div. Baxter Healthcare Corp. | GQS |
| Jun 4, 1987 | K870814 | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 Microscan Div. Baxter Healthcare Corp. | GQL |
| Apr 14, 1987 | K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS Microscan Div. Baxter Healthcare Corp. | JWY |
| Mar 31, 1987 | K871033 | RABBIT KIDNEY CULTURE CELLS (FIRST PASS) Microscan Div. Baxter Healthcare Corp. | KIR |
| Mar 17, 1987 | K870089 | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT Microscan Div. Baxter Healthcare Corp. | GTJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||