FDA product code KIS: Sera, Animal And Human
KIS is the FDA product code for sera, animal and human. It is a Class I device, regulated under 21 CFR 864.2800 and reviewed by the Pathology panel. FDA has cleared 45 510(k) submissions under KIS, from 17 different applicants. The average 510(k) review took 26 days (median 19). FDA has posted 1 recall for KIS devices.
Classification
| Field | Value |
|---|---|
| Device name | Sera, Animal And Human |
| Device class | Class I |
| Regulation | 21 CFR 864.2800 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIS clearance
Top KIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hyclone Laboratories, Inc. | 10 | 1988-04-04 |
| Hazleton Research Products, Inc. | 9 | 1986-05-20 |
| Dutchland Laboratories, Inc. | 9 | 1981-09-08 |
| Biolabs, Inc. | 3 | 1981-04-14 |
| Flow Laboratories, Inc. | 2 | 1986-03-10 |
12 more applicants have KIS clearances. See the full list in Caduvo.
Most recent KIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881287 | Cell Culture Laboratories | ANIMAL AND HUMAN SERA | 1988-04-05 | 8 |
| K880471 | Hyclone Laboratories, Inc. | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | 1988-04-04 | 61 |
| K880470 | Hyclone Laboratories, Inc. | BOVINE CALF SERUM CATALOG #A-2119 | 1988-04-01 | 58 |
| K872847 | Candace Lane Corp. | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | 1987-08-10 | 21 |
| K870580 | Rjo Biologicals, Inc. | MLC NORMAL SERUM | 1987-04-08 | 56 |
Recalls for KIS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-12.
Frequently asked questions
What is FDA product code KIS?
KIS is the FDA product code for sera, animal and human. It is a Class I device, regulated under 21 CFR 864.2800 and reviewed by the Pathology panel.
What device class is KIS?
Class I, regulation 21 CFR 864.2800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIS?
Across 45 cleared submissions the average was 26 days from receipt to decision (median 19).
Which companies have the most KIS clearances?
Hyclone Laboratories, Inc. (10); Hazleton Research Products, Inc. (9); Dutchland Laboratories, Inc. (9); Biolabs, Inc. (3); Flow Laboratories, Inc. (2).
Have KIS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code KIS
- Run a recall and safety report across every KIS manufacturer
- Watch product code KIS 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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