510(k) K812698
- Device
- Gc Disk
- Applicant
- REMEL CO.
- 510(k) number
- K812698
- Product code
- JTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-06
- Date received
- 1981-09-22
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | Micro-Bio-Logics | 1986-04-04 |
| 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 |