Submission Details
| 510(k) Number | K880798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1988 |
| Decision Date | April 18, 1988 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
ACID PHOSPHATASE REAGENT
Apr 1988
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K880798 is an FDA 510(k) clearance for the ACID PHOSPHATASE REAGENT, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on April 18, 1988, 52 days after receiving the submission on February 26, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.
Device Classification
| Product Code | CKB — Acid Phosphatase, Naphthyl Phosphate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1020 |
Manufacturer
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