510(k) K922870
- Device
- THREE SPIKE CUP
- Applicant
- OSTEO TECHNOLOGY, INC.
- 510(k) number
- K922870
- Product code
- GRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-08
- Date received
- 1992-06-04
- Regulation
- 866.3520
- Classification name
- Antiserum, Cf, Rubeola
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM SON
- Address
- 10 W. Aylesbury Rd. Timonium MD US 21093 21093
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852932 | MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT | Microbix Biosystems, Inc. | 1985-11-12 |
Legacy Summary#
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FDA Review#
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