K924192 is an FDA 510(k) clearance for the I.V. START KIT (AHC-50-54954. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by American Healthcare Corp. (South Plainfield, US). The FDA issued a Cleared decision on August 27, 1993, 372 days after receiving the submission on August 20, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K924192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | August 20, 1992 |
| Decision Date | August 27, 1993 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |