PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
FDA 510(k) clearance K902220 · decided 1990-09-05
Clearance details
- K-number
- K902220
- Device name
- PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-17
- Decision date
- 1990-09-05
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- DGR
- Device class
- 1
- Regulation number
- 866.5700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544) | Consolidated Technologies, Inc. | 1996-09-24 |
| LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014) | Bio-Rad | 1987-01-09 |
| RADIOASSAY, CONTROL SERUM I, II, III (K790298) | Kallestad Laboratories, Inc. | 1979-04-04 |
| ICS NORMAL CONTROL SERUM (K781355) | Beckman Instruments, Inc. | 1978-08-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |