510(k) K852932
- Device
- MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
- Applicant
- MICROBIX BIOSYSTEMS, INC.
- 510(k) number
- K852932
- Product code
- GRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-12
- Date received
- 1985-07-09
- Regulation
- 866.3520
- Classification name
- Antiserum, Cf, Rubeola
- Medical specialty
- Microbiology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J GASTLE
- Address
- 341 Bering Ave. Toronto, Ontario M9a 4x3 Canada CA
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922870 | THREE SPIKE CUP | Osteo Technology, Inc. | 1993-04-08 |
Legacy Summary#
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FDA Review#
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