EGG YOLK AGAR
FDA 510(k) clearance K831827 · decided 1983-07-26
Clearance details
- K-number
- K831827
- Device name
- EGG YOLK AGAR
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1983-06-07
- Decision date
- 1983-07-26
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JSH
- Device class
- 1
- Regulation number
- 866.2320
- 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 |
|---|---|---|
| DNASE TEST AGAR (K881486) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA AGAR BASE (K881559) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| RUSSELL DOUBLE SUGAR AGAR (K881553) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA BROTH (K881560) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHENOL RED BROTH BASE (K881551) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| FLO AGAR (K881540) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MOELLERS DECARBOXYLASE, BASE (K880121) | Hardy Media | 1988-03-31 |
| OF MEDIUM BASE (K880117) | Hardy Media | 1988-03-30 |
| ACTINOMYCETE DIFFERENTIAL MEDIA (K873270) | Central Media | 1987-11-04 |
| MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (K873263) | Central Media | 1987-10-28 |
| SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (K873411) | Lakewood Biochemical Co., Inc. | 1987-10-06 |
| MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 (K873704) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
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 |