A O HISTOSTAT EMBEDDING CTR #8030,32,34
FDA 510(k) clearance K821831 · decided 1982-07-13
Clearance details
- K-number
- K821831
- Device name
- A O HISTOSTAT EMBEDDING CTR #8030,32,34
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-22
- Decision date
- 1982-07-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IDS
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S004) | Warner-Lambert Co. | 1988-04-12 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S003) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S002) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S001) | Warner-Lambert Co. | 1983-11-25 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024) | Warner-Lambert Co. | 1982-03-04 |