NUCLIPASE (I125) PANCREATIC LIPASE
FDA 510(k) clearance K823860 · decided 1983-04-18
Clearance details
- K-number
- K823860
- Device name
- NUCLIPASE (I125) PANCREATIC LIPASE
- Applicant
- Nuclear Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-22
- Decision date
- 1983-04-18
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- CET
- Device class
- 1
- Regulation number
- 862.1465
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| LIPASE REAGENT SET (COLIPASE METHOD) (K970124) | Teco Diagnostics | 1997-03-06 |
| LIPASE REAGENT SYSTEM (K940457) | Medical Diagnostic Technologies, Inc. | 1994-06-02 |
| LIPASE REAGENT SET (K915706) | Tech Intl. Co. | 1992-02-18 |
| MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (K901858) | E.I. Dupont DE Nemours & Co., Inc. | 1990-06-12 |
| DELTATEST (R) LIPASE II (K893718) | Electro-Nucleonics, Inc. | 1989-09-28 |
| LIPASE SR LIQUID STABLE REAGENT SET (K885078) | Medical Analysis Systems, Inc. | 1989-03-13 |
| BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438) | Beckman Instruments, Inc. | 1987-03-12 |
| PARAMAX LIPASE REAGENT (K862440) | American Dade | 1986-08-04 |
| ENZYGNOST LIPASE TEST (K844240) | Behring Diagnostics, Inc. | 1985-02-12 |
| LIPASE (K812794) | Pointe Scientific, Inc., | 1981-10-20 |
| LIPASE TEST KIT (K792289) | Mallinckrodt Critical Care | 1979-12-18 |
| HARLECO BRAND CLINICARD LIPASE TEST SET (K791922) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-27 |
Recalls involving this device
No recalls on record reference this clearance.