FDA product code KZI: Culture Media, Enriched
KZI is the FDA product code for culture media, enriched. It is a Class I device, regulated under 21 CFR 866.2330 and reviewed by the Microbiology panel. FDA has cleared 51 510(k) submissions under KZI, from 20 different applicants. The average 510(k) review took 41 days (median 31). FDA has posted 2 recalls for KZI devices.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Enriched |
| Device class | Class I |
| Regulation | 21 CFR 866.2330 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZI clearance
Top KZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Media | 9 | 1988-03-31 |
| Lakewood Biochemical Co., Inc. | 6 | 1987-10-23 |
| Otisville Biotech, Inc. | 4 | 1986-07-03 |
| I.A.F. Production, Inc. | 3 | 1987-08-11 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1987-06-22 |
15 more applicants have KZI clearances. See the full list in Caduvo.
Most recent KZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884208 | Oxoid U.S.A., Inc. | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | 1988-10-25 | 19 |
| K881995 | Remel Co. | DIAMOND'S MEDIUM MODIFIED | 1988-06-02 | 21 |
| K880131 | Hardy Media | LOWENSTEIN-JENSEN, GRUFT | 1988-03-31 | 85 |
| K880134 | Hardy Media | MIDDLEBROOK 7H11 AGAR | 1988-03-31 | 85 |
| K880122 | Hardy Media | MIDDLEBROOK 7H9 BROTH | 1988-03-31 | 85 |
Recalls for KZI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-02-19.
Frequently asked questions
What is FDA product code KZI?
KZI is the FDA product code for culture media, enriched. It is a Class I device, regulated under 21 CFR 866.2330 and reviewed by the Microbiology panel.
What device class is KZI?
Class I, regulation 21 CFR 866.2330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZI?
Across 51 cleared submissions the average was 41 days from receipt to decision (median 31).
Which companies have the most KZI clearances?
Hardy Media (9); Lakewood Biochemical Co., Inc. (6); Otisville Biotech, Inc. (4); I.A.F. Production, Inc. (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (3).
Have KZI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code KZI
- Run a recall and safety report across every KZI manufacturer
- Watch product code KZI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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