510(k) K844547
- Device
- TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
- Applicant
- BIO MERIEUX, INC.
- 510(k) number
- K844547
- Product code
- JSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-16
- Date received
- 1984-11-21
- Regulation
- 866.2360
- Classification name
- Culture Media, Selective Broth
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICKI A MAXWELL
- Address
- 421 Irmen Dr. Addison IL US 60101 60101
FDA Registration Numbers#
- 1119779
- 3006158025
- 3005182159
- 3015715780
- 1111096
- 2022807
- 2436875
- 3009307598
- 3038136284
- 1924669
- 3005182157
- 8010096
- 1210083
- 9680687
- 9615755
- 3009547954
- 3002444944
- 1114298
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883075 | FASTIDIOUS INOCULUM BROTH | Baxter Healthcare Corp | 1988-08-15 |
| K880107 | CAMPY BROTH | Hardy Media | 1988-03-30 |
| K873324 | SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| K873218 | BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| K871640 | ALKALINE PEPTONE WATER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-13 |
| K871447 | TODD HEWITT W/CNA (LIM BROTH) | Remel Co. | 1987-05-13 |
| K870594 | T9802 TSB W/6.5% NACL | Lakewood Biochemical Co., Inc. | 1987-03-30 |
| K853609 | APL TRYPTIC SOY BROTH | Apl Medical Supplies | 1985-09-12 |
| K841836 | SELECTIVE CULTURE MED. TRICHOMONAS | Microline Scientific | 1984-05-14 |
| K840971 | SELECTIVE CULTURE MEDIUM | Chatham Biological | 1984-04-13 |
| K841211 | SELECTIVE BROTH | Smith River Biologicals | 1984-04-05 |
| K834013 | SF BROTH | Micro Media Laboratories | 1983-12-27 |
| K834015 | SELENITE BROTH | Micro Media Laboratories | 1983-12-22 |
| K833759 | GROUP STREP BROTH T3472 LIM | Gibco Laboratories Life Technologies, Inc. | 1983-12-16 |
| K832310 | ROGOSA BROTH | Oxoid U.S.A., Inc. | 1983-09-01 |
Legacy Summary#
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FDA Review#
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