510(k) K880544
- Device
- WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
- Applicant
- WESCOR, INC.
- 510(k) number
- K880544
- Product code
- GJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-01
- Date received
- 1988-02-09
- Regulation
- 864.1850
- Classification name
- Romanowsky Stains
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE K BARLOW
- Address
- 459 S. Main Logan UT US 84321 84321
FDA Registration Numbers#
- 3002809144
- 3040937533
- 3002805583
- 3016438761
- 2013736
- 3011558129
- 3009000266
- 3005333358
- 3044854712
- 3017970519
- 2247035
- 3033524192
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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