GOLD FILM MERCURY ANALYZER #511
FDA 510(k) clearance K832933 · decided 1983-11-25
Clearance details
- K-number
- K832933
- Device name
- GOLD FILM MERCURY ANALYZER #511
- Applicant
- Jerome Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-30
- Decision date
- 1983-11-25
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DPH
- Device class
- 1
- Regulation number
- 862.3600
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, 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 |
|---|---|---|
| MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS (K781010) | The Perkin-Elmer Corp. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.