DIAMOND'S MEDIUM MODIFIED
FDA 510(k) clearance K881995 · decided 1988-06-02
Clearance details
- K-number
- K881995
- Device name
- DIAMOND'S MEDIUM MODIFIED
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-12
- Decision date
- 1988-06-02
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KZI
- Device class
- 1
- Regulation number
- 866.2330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, 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 |
| 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 |
| MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 (K873952) | Lakewood Biochemical Co., Inc. | 1987-10-23 |
Recalls involving this device
No recalls on record reference this clearance.