Company ยท US
Abbott Mfg., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1998. 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 |
|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 |
| FRN | Pump, Infusion | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| CJY | Azo Dye, Calcium | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| LZH | Pump, Infusion, Enteral | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 1998 | K981457 | ALBP Abbott Mfg., Inc. | CJW |
| May 18, 1998 | K981232 | CA Abbott Mfg., Inc. | CJY |
| May 12, 1998 | K981231 | CO2 Abbott Mfg., Inc. | KHS |
| Jul 3, 1997 | K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP Abbott Mfg., Inc. | FRN |
| Jun 27, 1997 | K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE Abbott Mfg., Inc. | FPA |
| Oct 3, 1995 | K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) Abbott Mfg., Inc. | CFT |
| Sep 25, 1995 | K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) Abbott Mfg., Inc. | CFT |
| Jul 24, 1995 | K944669 | FLEXIFLO QUANTUM ENTERAL PUMP Abbott Mfg., Inc. | FRN |
| Mar 23, 1995 | K943691 | IMX FOLATE Abbott Mfg., Inc. | CGN |
| Dec 12, 1994 | K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP Abbott Mfg., Inc. | LZH |
| Oct 3, 1994 | K941214 | LIFESHIELD EXTENSION SET Abbott Mfg., Inc. | FPK |
| Jul 18, 1994 | K940289 | ABBOTT PRISM ANALYZER Abbott Mfg., Inc. | JJE |
| Jun 21, 1994 | K935376 | AXSYM GENTAMICIN Abbott Mfg., Inc. | LCD |
| Jul 10, 1990 | K902753 | IMX ULTRASENTITIVE HTSH Abbott Mfg., Inc. | JLW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||