PROTECT T.M.
FDA 510(k) clearance K871121 · decided 1987-04-14
Clearance details
- K-number
- K871121
- Device name
- PROTECT T.M.
- Applicant
- Pro-Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-19
- Decision date
- 1987-04-14
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- JTR
- Device class
- 1
- Regulation number
- 866.2480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough Ont, CA
- 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 |
|---|---|---|
| FEKAL CHECK PARASITOLOGY CONTROL SLIDE (K862914) | Trend Scientific, Inc. | 1986-09-16 |
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |
| INDI KWIK (TM) CO/TWO KIT (K855198) | Micro-Bio-Logics | 1986-01-14 |
| B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579) | Biological & Environmental Control Laboratories | 1984-07-27 |
| LYFO-DISK MICROORGANISMS (K842129) | Micro-Bio-Logics | 1984-07-03 |
| LYOPHILIZED MICROORGANISMS (K831653) | Austin Biological Laboratories | 1983-07-28 |
| Q-CHECK CULTI-LOOPS (K830133) | Lab Ability, Inc. | 1983-02-09 |
| MICROTECH BACTERIAL CONTROLS (K822954) | Universal Micro Reference Laboratory | 1982-11-16 |
| BIO-CHECK GRAM STAIN CONTROL (K821660) | American Scientific Products | 1982-06-25 |
| SUSCEPTROL (K820064) | American Type Culture Collection | 1982-01-28 |
| GC DISK (K812698) | Remel Co. | 1981-10-06 |
Recalls involving this device
No recalls on record reference this clearance.