510(k) K771955
- Device
- TRYPSIN 1%
- Applicant
- FLOW LABORATORIES, INC.
- 510(k) number
- K771955
- Product code
- IBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-22
- Date received
- 1977-10-17
- Regulation
- 864.4400
- Classification name
- Trypsin
- Medical specialty
- Pathology
- Review panel
- Microbiology
- 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#
- 3014053517
- 3006158025
- 3005182159
- 3010939897
- 3003646592
- 3005182157
- 3004074729
- 3008776165
- 3038624837
- 2028492
- 3016090200
- 1114298
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IBG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K802493 | SPUTASOL | Oxoid U.S.A., Inc. | 1980-11-12 |
Legacy Summary#
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FDA Review#
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