Product code KZI
- Device name
- Culture Media, Enriched
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2330
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | Oxoid U.S.A., Inc. | 1988-10-25 |
| K881995 | DIAMOND'S MEDIUM MODIFIED | Remel Co. | 1988-06-02 |
| K880134 | MIDDLEBROOK 7H11 AGAR | Hardy Media | 1988-03-31 |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | Hardy Media | 1988-03-31 |
| K880122 | MIDDLEBROOK 7H9 BROTH | Hardy Media | 1988-03-31 |
| K880138 | WALLENSTEIN MEDIUM SLANT | Hardy Media | 1988-03-30 |
| K880109 | CYSTINE TRYPTIC MEDIUM BASE | Hardy Media | 1988-03-30 |
| K880127 | POTATO DEXTROSE AGAR | Hardy Media | 1988-03-07 |
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | Otisville Biopharm, Inc. | 1988-01-28 |
| K874177 | BIOTIS (TM) BCYE | Otisville Biopharm, Inc. | 1987-12-04 |
| K873267 | ECG BASED MEDIA | Central Media | 1987-11-04 |
| K873266 | MIDDLEBROOK BASED MEDIA | Central Media | 1987-10-28 |
| K873952 | MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 | Lakewood Biochemical Co., Inc. | 1987-10-23 |
| K873321 | SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 | Lakewood Biochemical Co., Inc. | 1987-09-29 |
| K873320 | SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD | Lakewood Biochemical Co., Inc. | 1987-09-29 |
| K873061 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405 | Lakewood Biochemical Co., Inc. | 1987-08-24 |
| K873060 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002 | Lakewood Biochemical Co., Inc. | 1987-08-24 |
| K873058 | TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810 | Lakewood Biochemical Co., Inc. | 1987-08-24 |
| K872685 | IAFP LOWENSTEIN JENSEN SLANT | I.A.F. Production, Inc. | 1987-08-11 |
| K872678 | IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 | I.A.F. Production, Inc. | 1987-08-07 |
| K872671 | IAFP T.S.A. W/5% SHEEP BLOOD | I.A.F. Production, Inc. | 1987-08-07 |
| K872193 | FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-06-22 |
| K870634 | TETRATHIONATE BROTH | Hardy Media | 1987-04-14 |
| K870646 | MIDDLEBROOK 7H10 AGAR | Hardy Media | 1987-04-14 |
| K870642 | COOKED MEAT MEDIUM WITH IRON | Hardy Media | 1987-04-14 |
| K871092 | HORSE BLOOD AGAR, ENRICHED | bioMerieux, Inc. | 1987-04-03 |
| K864238 | CHOCOLATE AGAR | Mds Laboratories, Inc. | 1987-03-31 |
| K864014 | LOMBARD DOWELL AGAR BASE | Gibco Laboratories Life Technologies, Inc. | 1986-10-29 |
| K862761 | VACUTAINER BRAND AGAR SLANT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-08-04 |
| K862390 | BIOTIS BORDET GENGOU AGAR | Otisville Biotech, Inc. | 1986-07-03 |
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| 10819398028209 | N/A | HARDY DIAGNOSTICS | 2020-05-11 |
| 00816576023875 | N/A | HARDY DIAGNOSTICS | 2020-05-11 |
| 00816576023721 | N/A | HARDY DIAGNOSTICS | 2020-05-11 |
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| 10382902211690 | BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™) | BECTON, DICKINSON AND COMPANY | 2016-12-21 |