PEPTONE YEAST EXTRACT GLUCOSE BROTH
FDA 510(k) clearance K803026 · decided 1980-12-22
Clearance details
- K-number
- K803026
- Device name
- PEPTONE YEAST EXTRACT GLUCOSE BROTH
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1980-11-26
- Decision date
- 1980-12-22
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- JSC
- Device class
- 1
- Regulation number
- 866.2350
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPORDEX CULTURE MEDIA (K850143) | American Sterilizer Co. | 1985-03-05 |
| BRAIN HEART INFUSION BROTH (K842852) | Anarobe Systems | 1984-08-03 |
| TRYPTICASE SOY BROTH (K842849) | Anarobe Systems | 1984-08-03 |
| BRAIN HEART INFUSION BROTH (K841221) | Anaerobe Systems | 1984-04-04 |
| SHOPPED MEAT CARBOHYDRATE (K841219) | Anaerobe Systems | 1984-04-04 |
| SABOURAUD BHI AGAR (K833300) | Acumedia Manufacturers, Inc. | 1983-11-07 |
| TRYPTIC SOY BROTH MEDIA (K832620) | Carroll Biological Corp. | 1983-09-12 |
| INFUSION BROTH (K832569) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| EXTRACT BROTH (K832570) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| THIOGLYCOLLATE MEDIUM (K832619) | Carroll Biological Corp. | 1983-09-12 |
| CHS (K830437) | Dms Laboratories | 1983-03-17 |
| WILKINS-CHALGREN ANAEROBE BROTH (K822665) | Oxoid U.S.A., Inc. | 1982-09-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |