PARA-PAK(WHEATLEY'S TRICHROME STAIN)
FDA 510(k) clearance K792706 · decided 1980-01-24
Clearance details
- K-number
- K792706
- Device name
- PARA-PAK(WHEATLEY'S TRICHROME STAIN)
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-01-24
- Days to decision
- 28 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
+ Add to Predicate Builder ◉ Watch Meridian Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DROPPER, SOLUTION TRICHROME, CEPTI-SEAL (K781062) | Marion Laboratories, Inc. | 1978-08-14 |
Recalls involving this device
No recalls on record reference this clearance.