510(k) K832953
- Device
- Mucicarmine Stain, #ht30
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K832953
- Product code
- HZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-29
- Date received
- 1983-08-31
- Regulation
- 864.1850
- Classification name
- Mucicarmine
- Medical specialty
- Hematology
- Review panel
- Hematology
- 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
- 3015614371
- 1831638
- 3007496191
- 3004074729
- 3008776165
- 1937990
- 2013736
- 1419699
- 1219125
- 3009189893
- 2250039
- 1831338
- 2028492
- 2022180
- 2916205
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HZC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842925 | MUCI-CARMINE STAIN, MAYER'S FORMULA | E K Ind., Inc. | 1984-09-11 |