510(k) K831131
- Device
- Case Wright-giemsa Stain Pak
- Applicant
- CASE INSTRUMENTS
- 510(k) number
- K831131
- Product code
- HYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-08
- Date received
- 1983-04-06
- Regulation
- 864.1850
- Classification name
- Giemsa Stain
- 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#
- 1937990
- 9610140
- 1625587
- 3009963993
- 2518071
- 3002805583
- 1930126
- 1000138378
- 3006365273
- 1045125
- 1924669
- 3004074729
- 1640981
- 1613616
- 2247035
- 3030446844
- 3008776165
- 2013736
- 1419699
- 3009189893
- 2250039
- 3021584593
- 2022180
- 2025606
- 1125908
- 3017970519
- 1831638
- 3009432145
- 1711690
- 3030733800
- 3016741564
- 2028492
- 2916205
- 2432235
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA