AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
FDA 510(k) clearance K855034 · decided 1986-03-11
Clearance details
- K-number
- K855034
- Device name
- AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-17
- Decision date
- 1986-03-11
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LIJ
- Device class
- 1
- Regulation number
- 864.4400
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Bellevue, WA, 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 |
|---|---|---|
| DAKO PAP KIT K509 (K820336) | Dako Corp. | 1982-07-13 |
Recalls involving this device
No recalls on record reference this clearance.