Micro Detect, Inc.
Tustin, CA, US
MICRO DETECT, INC. appears in FDA device records in Tustin, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Micro Detect, Inc. between 1998 and 2001. The busiest year on record is 2000, with 9. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 9 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003794 | ELISA TEST, SEROLOGY | LYR | Substantially Equivalent | |
| K002359 | MDI GLIADIN G TEST | MST | Substantially Equivalent | |
| K002358 | MDI GLIADIN A TEST | MST | Substantially Equivalent | |
| K000934 | MDI SCL-70 TEST | LJM | Substantially Equivalent | |
| K000477 | MDI DS-DNA TEST | LRM | Substantially Equivalent | |
| K994029 | MDI SM TEST | LLL | Substantially Equivalent | |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | LLL | Substantially Equivalent | |
| K993843 | MDI RF TEST | DHR | Substantially Equivalent | |
| K993636 | MDI SS-A TEST | LJM | Substantially Equivalent | |
| K993635 | MDI SM/RNP TEST | LJM | Substantially Equivalent | |
| K973508 | PYLORI DETECT IGG | LYR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031341 | 3001697474 | MICRO DETECT, INC. | 2852 WALNUT AVE., SUITE H-1, TUSTIN, CA 92780 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain