K942245 is an FDA 510(k) clearance for the BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 3, 1995, 329 days after receiving the submission on May 9, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K942245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1994 |
| Decision Date | April 03, 1995 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |