510(k) K770833
- Device
- FLUORETEC-M
- Applicant
- Pfizer, Inc.
- 510(k) number
- K770833
- Product code
- GMY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-08
- Date received
- 1977-05-06
- Regulation
- 866.3255
- Classification name
- Antisera, Fluorescent, All Types, Escherichia Coli
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770801 | MICROBIO. PROD. FLUORESCENT ANTIBODY | Pfizer Pharmaceuticals | 1977-05-25 |