REAGENT SET TRIGLYCERIDES
FDA 510(k) clearance K811553 · decided 1981-06-18
Clearance details
- K-number
- K811553
- Device name
- REAGENT SET TRIGLYCERIDES
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-02
- Decision date
- 1981-06-18
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- CHI
- Device class
- 1
- Regulation number
- 862.1465
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905) | Beckman Instruments, Inc. | 1997-06-04 |
| SENTINEL LIPASE LIQUID MODEL 17.401B (K961179) | Equal Diagnostics, Inc. | 1996-07-19 |
| CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180) | Beckman Instruments, Inc. | 1995-08-17 |
| IL TEST LIPASE (K952647) | Instrumentation Laboratory CO | 1995-07-20 |
| LIPASE FLEX REAGENT CARTRIDGE (K952816) | Dupont Medical Products | 1995-07-20 |
| LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085) | Sigma Diagnostics, Inc. | 1994-05-17 |
| ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (K923917) | Nuclear Diagnostics, Inc. | 1994-02-25 |
| WAKO AUTOKIT LIPASE-COLOR (K921249) | Wako Chemicals USA, Inc. | 1992-07-21 |
| MILES LIPASE SERA-PAK METHOD (K920337) | Heraeus Kulzer, Inc. | 1992-03-11 |
| COLORIMETRIC CHLORIDE PRODUCT #4314125 (K900827) | American Research Products Co. | 1990-05-02 |
| LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150) | Toyo Jozo Co., Ltd. | 1990-02-26 |
| ABBOTT A-GENT LIPASE REAGENT (K884596) | Abbott Laboratories | 1988-12-06 |
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 |