TOTAL LIPIDS REAGENT SET
FDA 510(k) clearance K860112 · decided 1986-01-24
Clearance details
- K-number
- K860112
- Device name
- TOTAL LIPIDS REAGENT SET
- Applicant
- Technostics Intl.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-13
- Decision date
- 1986-01-24
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- CFD
- Device class
- 1
- Regulation number
- 862.1470
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, 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 |
|---|---|---|
| TOTAL LIPIDS (K863073) | J. D. Assoc. | 1986-09-09 |
| TOTAL LIPID REAGENT SET (K820500) | Anco Medical Reagents & Assoc. | 1982-03-11 |
| LIPID PROFILE (K813469) | Bio-Analytics Laboratories, Inc. | 1981-12-31 |
Recalls involving this device
No recalls on record reference this clearance.