510(k) K861022
- Device
- KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
- Applicant
- MICRO-BIO-LOGICS
- 510(k) number
- K861022
- Product code
- JTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-04
- Date received
- 1986-03-18
- Regulation
- 866.2480
- Classification name
- Kit, Quality Control For Culture Media
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GERALD TJERNAGEL
- Address
- 217 Osseo Ave. N. St. Cloud MN US 56301 56301
FDA Registration Numbers#
- 2150138
- 2030538
- 3015715780
- 3006091463
- 1050138
- 2436875
- 1924669
- 2518630
- 9610649
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871121 | PROTECT T.M. | Pro-Lab, Inc. | 1987-04-14 |
| K862914 | FEKAL CHECK PARASITOLOGY CONTROL SLIDE | Trend Scientific, Inc. | 1986-09-16 |
| K855198 | INDI KWIK (TM) CO/TWO KIT | Micro-Bio-Logics | 1986-01-14 |
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | Biological & Environmental Control Laboratories | 1984-07-27 |
| K842129 | LYFO-DISK MICROORGANISMS | Micro-Bio-Logics | 1984-07-03 |
| K831653 | LYOPHILIZED MICROORGANISMS | Austin Biological Laboratories | 1983-07-28 |
| K830133 | Q-CHECK CULTI-LOOPS | Lab Ability, Inc. | 1983-02-09 |
| K822954 | MICROTECH BACTERIAL CONTROLS | Universal Micro Reference Laboratory | 1982-11-16 |
| K821660 | BIO-CHECK GRAM STAIN CONTROL | American Scientific Products | 1982-06-25 |
| K820064 | SUSCEPTROL | American Type Culture Collection | 1982-01-28 |
| K812698 | GC DISK | Remel Co. | 1981-10-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases