510(k) K790796
- Device
- LIPASE REAGENT SET
- Applicant
- ALTA DIAGNOSTICS, INC.
- 510(k) number
- K790796
- Product code
- CET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-07-17
- Date received
- 1979-04-24
- Regulation
- 862.1465
- Classification name
- Olive Oil Emulsion (turbidimetric), Lipase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610126
- 3006198300
- 1832216
- 8040374
- 3008517993
- 3003795116
- 3021841051
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CET #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | Teco Diagnostics | 1997-03-06 |
| K940457 | LIPASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1994-06-02 |
| K915706 | LIPASE REAGENT SET | Tech Intl. Co. | 1992-02-18 |
| K901858 | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | 1990-06-12 |
| K893718 | DELTATEST (R) LIPASE II | Electro-Nucleonics, Inc. | 1989-09-28 |
| K885078 | LIPASE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1989-03-13 |
| K864438 | BECKMAN EPSILON(TM) LIPASE TEST KIT | Beckman Instruments, Inc. | 1987-03-12 |
| K862440 | PARAMAX LIPASE REAGENT | American Dade | 1986-08-04 |
| K844240 | ENZYGNOST LIPASE TEST | Behring Diagnostics, Inc. | 1985-02-12 |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Nuclear Diagnostics, Inc. | 1983-04-18 |
| K812794 | LIPASE | Pointe Scientific, Inc., | 1981-10-20 |
| K792289 | LIPASE TEST KIT | Mallinckrodt Critical Care | 1979-12-18 |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-27 |
| K770364 | ACA LIPASE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-15 |
Legacy Summary#
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FDA Review#
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