FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
FDA 510(k) clearance K872193 · decided 1987-06-22
Clearance details
- K-number
- K872193
- Device name
- FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1987-06-08
- Decision date
- 1987-06-22
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KZI
- Device class
- 1
- Regulation number
- 866.2330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lakes, NJ, 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 |
|---|---|---|
| LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208) | Oxoid U.S.A., Inc. | 1988-10-25 |
| DIAMOND'S MEDIUM MODIFIED (K881995) | Remel Co. | 1988-06-02 |
| MIDDLEBROOK 7H9 BROTH (K880122) | Hardy Media | 1988-03-31 |
| MIDDLEBROOK 7H11 AGAR (K880134) | Hardy Media | 1988-03-31 |
| LOWENSTEIN-JENSEN, GRUFT (K880131) | Hardy Media | 1988-03-31 |
| WALLENSTEIN MEDIUM SLANT (K880138) | Hardy Media | 1988-03-30 |
| CYSTINE TRYPTIC MEDIUM BASE (K880109) | Hardy Media | 1988-03-30 |
| POTATO DEXTROSE AGAR (K880127) | Hardy Media | 1988-03-07 |
| BIOTIS (TM) SABHI (DOUBLE POUR) (K874179) | Otisville Biopharm, Inc. | 1988-01-28 |
| BIOTIS (TM) BCYE (K874177) | Otisville Biopharm, Inc. | 1987-12-04 |
| ECG BASED MEDIA (K873267) | Central Media | 1987-11-04 |
| MIDDLEBROOK BASED MEDIA (K873266) | Central Media | 1987-10-28 |
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 |