TRICHINELLA SEROLOGY MICROTITER ELISA
FDA 510(k) clearance K904613 · decided 1991-03-21
Clearance details
- K-number
- K904613
- Device name
- TRICHINELLA SEROLOGY MICROTITER ELISA
- Applicant
- Lmd Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-10-11
- Decision date
- 1991-03-21
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- GPG
- Device class
- 1
- Regulation number
- 866.3850
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MINIFUGE, MODEL 70 (K882149) | Utah Bioresearch, Inc. | 1988-07-01 |
Recalls involving this device
No recalls on record reference this clearance.