TOTAL LIPIDS
FDA 510(k) clearance K863073 · decided 1986-09-09
Clearance details
- K-number
- K863073
- Device name
- TOTAL LIPIDS
- Applicant
- J. D. Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-12
- Decision date
- 1986-09-09
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- CFD
- Device class
- 1
- Regulation number
- 862.1470
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Montclair, NJ, 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 REAGENT SET (K860112) | Technostics Intl. | 1986-01-24 |
| 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.