510(k) K882149
- Device
- MINIFUGE, MODEL 70
- Applicant
- UTAH BIORESEARCH, INC.
- 510(k) number
- K882149
- Product code
- GPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-01
- Date received
- 1988-05-23
- Regulation
- 866.3850
- Classification name
- Antigen, Latex Agglutination, Trichinella Spiralis
- Medical specialty
- Microbiology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM S PARTRIDGE
- Address
- Suite 222 410 Chipeta Way Salt Lake City UT US 84108 84108
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GPG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904613 | TRICHINELLA SEROLOGY MICROTITER ELISA | Lmd Laboratories | 1991-03-21 |
Legacy Summary#
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FDA Review#
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