Submission Details
| 510(k) Number | K960436 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 1996 |
| Decision Date | March 19, 1996 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
K960436 - SELFCARE EARLY PREGNANCY TEST
(FDA 510(k) Clearance)
Mar 1996
Decision
48d
Days
Class 2
Risk
K960436 is an FDA 510(k) clearance for the SELFCARE EARLY PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX).
Submitted by Selfcare, Inc. (Galway, IE). The FDA issued a Cleared decision on March 19, 1996, 48 days after receiving the submission on January 31, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
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