510(k) K860485
- Device
- SGPT (ALT) REAGENT SET (COLORIMETRIC)
- Applicant
- STERLING DIAGNOSTICS, INC.
- 510(k) number
- K860485
- Product code
- CKD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-03
- Date received
- 1986-02-10
- Regulation
- 862.1030
- Classification name
- Hydrazone Colorimetry, Alt/sgpt
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID L CALLENDER
- Address
- 34210 Dequindre Rd. Sterling Heights MI US 48077 48077
FDA Registration Numbers#
- 1832216
- 3043648115
- 3010583458
- 3017936791
- 8040374
- 3010891909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CKD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Cholestech Corp. | 1999-09-09 |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1995-05-16 |
| K896237 | COBAS READY ALT REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Electro-Nucleonics, Inc. | 1988-12-29 |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-10-13 |
| K864082 | REFLOTRON(R) ALT (GPT) | Boehringer Mannheim Corp. | 1986-12-04 |
| K844283 | SGPT REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-27 |
| K841059 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K821207 | SGPT REAGENT SET | Omega Medical Electronics | 1982-07-14 |
| K820491 | SGPT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 |
Legacy Summary#
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FDA Review#
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