DROPPER, SOLUTION TRICHROME, CEPTI-SEAL
FDA 510(k) clearance K781062 · decided 1978-08-14
Clearance details
- K-number
- K781062
- Device name
- DROPPER, SOLUTION TRICHROME, CEPTI-SEAL
- Applicant
- Marion Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-26
- Decision date
- 1978-08-14
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HYW
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PARA-PAK(WHEATLEY'S TRICHROME STAIN) (K792706) | Meridian Diagnostics, Inc. | 1980-01-24 |
Recalls involving this device
No recalls on record reference this clearance.