510(k) K875259
- Device
- BITEK(TM) BLOOD CULTURE SYSTEM
- Applicant
- DEFINITIVE DIAGNOSTICS, INC.
- 510(k) number
- K875259
- Product code
- JSG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-27
- Date received
- 1987-12-22
- Regulation
- 866.2300
- Classification name
- Culture Media, Non-selective And Non-differential
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- GARY WICKLUND
- Address
- P.O. Box 578 Tualatin OR US 97062 97062
FDA Registration Numbers
- 3008007472
- 3016587486
- 3017830316
- 3009963993
- 3020831613
- 3018779125
- 1119779
- 3024647994
- 3018077536
- 3016635427
- 1125797
- 8010096
- 1210083
- 3017717188
- 1060680
- 1930987
- 1220477
- 3017467459
- 1043214
- 8044093
- 2919016
- 2951280
- 2030598
- 3017871324
- 3011649813
- 3015715780
- 3017170972
- 2436875
- 1055236
- 3005182157
- 3016741564
- 3005739529
- 1216735
- 1924669
- 3033815621
- 2016672
- 9615755
- 1111096
- 3016710934
- 3008236846
- 2022807
- 3009302820
- 3012162776
- 3016619649
- 3002444944
- 3015825358
- 3044466317
- 3005182159
- 1530248
- 1450405
- 8020040
- 3007478714
- 1616487
- 3000682787
- 3010420046
- 3016837106
- 3016764932
- 1054241
- 3009171251
- 3015505238
- 3017231634
- 3011676045
- 3016884191
- 3015069920
- 2916932
- 3022778613
- 3038136284
- 3009547954
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882495 | THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 | Lakewood Biochemical Co., Inc. | 1988-07-01 |
| K881564 | TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881563 | TRYPTOSE PHOSPHATE BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881562 | TRYPTOSE BLOOD AGAR BASE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881558 | TRYPTOSE AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881557 | TRYPTONE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881554 | SKIM MILK DEHYDRATED | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881550 | OF BASAL MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881548 | MPH AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881546 | MALT EXTRACT AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881545 | MALT EXTRACT | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881543 | LETHEEN AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881542 | HEART INFUSION AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881541 | GELATIN | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881533 | BLOOD AGAR BASE NO. 2 | Acumedia Manufacturers, Inc. | 1988-04-18 |
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