KZI · Culture Media, Enriched
Microbiology · 21 CFR 866.2330 · Class 1
Overview
| Product Code | KZI |
|---|---|
| Device Name | Culture Media, Enriched |
| Regulation | 21 CFR 866.2330 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (20 of 51)
Showing 20 most recent of 51 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | Oxoid U.S.A., Inc. | Oct 25, 1988 | SESE |
| K881995 | DIAMOND'S MEDIUM MODIFIED | Remel Co. | Jun 2, 1988 | SESE |
| K880134 | MIDDLEBROOK 7H11 AGAR | Hardy Media | Mar 31, 1988 | SESE |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | Hardy Media | Mar 31, 1988 | SESE |
| K880122 | MIDDLEBROOK 7H9 BROTH | Hardy Media | Mar 31, 1988 | SESE |
| K880138 | WALLENSTEIN MEDIUM SLANT | Hardy Media | Mar 30, 1988 | SESE |
| K880109 | CYSTINE TRYPTIC MEDIUM BASE | Hardy Media | Mar 30, 1988 | SESE |
| K880127 | POTATO DEXTROSE AGAR | Hardy Media | Mar 7, 1988 | SESE |
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | Otisville Biopharm, Inc. | Jan 28, 1988 | SESE |
| K874177 | BIOTIS (TM) BCYE | Otisville Biopharm, Inc. | Dec 4, 1987 | SESE |
| K873267 | ECG BASED MEDIA | Central Media | Nov 4, 1987 | SESE |
| K873266 | MIDDLEBROOK BASED MEDIA | Central Media | Oct 28, 1987 | SESE |
| K873952 | MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 | Lakewood Biochemical Co., Inc. | Oct 23, 1987 | SESE |
| K873321 | SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 | Lakewood Biochemical Co., Inc. | Sep 29, 1987 | SESE |
| K873320 | SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD | Lakewood Biochemical Co., Inc. | Sep 29, 1987 | SESE |
| K873061 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405 | Lakewood Biochemical Co., Inc. | Aug 24, 1987 | SESE |
| K873060 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002 | Lakewood Biochemical Co., Inc. | Aug 24, 1987 | SESE |
| K873058 | TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810 | Lakewood Biochemical Co., Inc. | Aug 24, 1987 | SESE |
| K872685 | IAFP LOWENSTEIN JENSEN SLANT | I.A.F. Production, Inc. | Aug 11, 1987 | SESE |
| K872678 | IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 | I.A.F. Production, Inc. | Aug 7, 1987 | SESE |
Top Applicants
- Hardy Media — 9 clearances
- Lakewood Biochemical Co., Inc. — 6 clearances
- Otisville Biotech, Inc. — 4 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- I.A.F. Production, Inc. — 3 clearances
