510(k) K792706
- Device
- PARA-PAK(WHEATLEY'S TRICHROME STAIN)
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- 510(k) number
- K792706
- Product code
- HYW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-24
- Date received
- 1979-12-27
- Regulation
- 864.1850
- Classification name
- Stain, Trichrome, Mallory's
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1000138378
- 3017970519
- 2247035
- 1831638
- 3014165737
- 3008776165
- 1937990
- 2013736
- 1524213
- 3002805583
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HYW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K781062 | DROPPER, SOLUTION TRICHROME, CEPTI-SEAL | Marion Laboratories, Inc. | 1978-08-14 |
Legacy Summary#
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FDA Review#
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