510(k) K904613
- Device
- TRICHINELLA SEROLOGY MICROTITER ELISA
- Applicant
- LMD LABORATORIES
- 510(k) number
- K904613
- Product code
- GPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-21
- Date received
- 1990-10-11
- Regulation
- 866.3850
- Classification name
- Antigen, Latex Agglutination, Trichinella Spiralis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVE LAMBILLOTTE
- Address
- 4626 Santa Fe St. San Diego CA US 92109 92109
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GPG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882149 | MINIFUGE, MODEL 70 | Utah Bioresearch, Inc. | 1988-07-01 |
Legacy Summary#
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FDA Review#
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