510(k) K833020
- Device
- CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER
- Applicant
- GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
- 510(k) number
- K833020
- Product code
- JSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-09-06
- Regulation
- 866.2450
- Classification name
- Supplement, 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#
- 3006158025
- 8010096
- 3015715780
- 2022807
- 3006091463
- 3014680809
- 2025606
- 3004107906
- 9610649
- 1318354
- 3005182157
- 8010383
- 3005182159
- 1114298
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881949 | ATS NAC-PAC SET | Alpha-Tec Systems, Inc. | 1988-05-25 |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | Alpha-Tec Systems, Inc. | 1988-05-13 |
| K881566 | HEMOGLOBIN POWDER | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Hazleton Research Products, Inc. | 1986-06-10 |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | Flow Laboratories, Inc. | 1986-05-20 |
| K855172 | KWI (TM) G-CO/TWO | Micro-Bio-Logics | 1986-02-20 |
| K853546 | ABBOTT CATION SUPPLEMENT SOLUTION | Abbott Laboratories | 1985-09-06 |
| K850302 | SUPLEX & SUPLEX DILUENT | Pro-Lab, Inc. | 1985-03-22 |
| K850301 | YEAST DIALYSATE | Pro-Lab, Inc. | 1985-03-20 |
| K850299 | C.N.V.T. | Pro-Lab, Inc. | 1985-03-20 |
| K850300 | MUCOLYSE | Pro-Lab, Inc. | 1985-03-20 |
| K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | Pro-Lab, Inc. | 1985-03-20 |
| K850308 | C.L.A.T. | Pro-Lab, Inc. | 1985-03-20 |
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