ENRICHED THIOGLYCOLLATE MEDIUM
FDA 510(k) clearance K803023 · decided 1980-12-22
Clearance details
- K-number
- K803023
- Device name
- ENRICHED THIOGLYCOLLATE MEDIUM
- 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
- JSG
- Device class
- 1
- Regulation number
- 866.2300
- 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 |
|---|---|---|
| THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495) | Lakewood Biochemical Co., Inc. | 1988-07-01 |
| OF BASAL MEDIUM (K881550) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE AGAR (K881558) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DEXTROSE TRYPTONE BROTH (K881523) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BLOOD AGAR BASE W/LOW PH (K881532) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTONE (K881557) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| HEART INFUSION AGAR (K881542) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE PHOSPHATE BROTH (K881563) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DEXTROSE AGAR (K881522) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MALT EXTRACT (K881545) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SKIM MILK DEHYDRATED (K881554) | Acumedia Manufacturers, Inc. | 1988-04-18 |
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 |