HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
FDA 510(k) clearance K881477 · decided 1988-04-18
Clearance details
- K-number
- K881477
- Device name
- HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
- Applicant
- Stat Path
- Decision
- Substantially Equivalent
- Date received
- 1988-04-07
- Decision date
- 1988-04-18
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- KEL
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Riderwood, MD, 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 |
|---|---|---|
| ATS MAYER'S ALBUMIN (K890022) | Alpha-Tec Systems, Inc. | 1989-01-10 |
Recalls involving this device
No recalls on record reference this clearance.