KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
FDA 510(k) clearance K861022 · decided 1986-04-04
Clearance details
- K-number
- K861022
- Device name
- KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
- Applicant
- Micro-Bio-Logics
- Decision
- Substantially Equivalent
- Date received
- 1986-03-18
- Decision date
- 1986-04-04
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- JTR
- Device class
- 1
- Regulation number
- 866.2480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- St. Cloud, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| PROTECT T.M. (K871121) | Pro-Lab, Inc. | 1987-04-14 |
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| 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 |