ENZYMUN TEST(R) INSULIN
FDA 510(k) clearance K901135 · decided 1990-04-03
Clearance details
- K-number
- K901135
- Device name
- ENZYMUN TEST(R) INSULIN
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-12
- Decision date
- 1990-04-03
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- CFP
- Device class
- 1
- Regulation number
- 862.1405
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| ALPCO/MERCODIA INSULIN ELISA (K963911) | American Laboratory Products Co., Ltd. | 1996-11-01 |
| ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084) | Bio-Rad Laboratories, Inc. | 1995-09-25 |
| IMX INSULIN (K920109) | Abbott Laboratories | 1992-05-07 |
| DSL INSULIN RIA (DSL 1600) (K914820) | Diagnostic Systems Laboratories, Inc. | 1992-01-09 |
| AIA-PACK IRI (K903628) | Tosoh Corp. | 1990-09-07 |
| REP(TM) SPE PLUS-30 PROCEDURES (K896572) | Helena Laboratories | 1990-01-11 |
| RIA-GNOST INSULIN (K890837) | Cambridge Medical Technology | 1989-04-26 |
| PHARMACIA INSULIN RIA (K851071) | Pharmacia, Inc. | 1985-04-12 |
| INSULIN RADIOIMMUNOASSAY KIT (K841573) | Sorin Biomedica, Fiat, USA, Inc. | 1984-05-16 |
| WAKO INSULIN TEST (K823939) | Wako Chemicals USA, Inc. | 1983-01-28 |
| COVALENT COAT RIA KIT (K822509) | Immuchem Corp. | 1982-09-28 |
| COAT-A-COUNT INSULIN KIT (K821861) | Diagnostic Products Corp. | 1982-07-08 |
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 |