Submission Details
| 510(k) Number | K002049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2000 |
| Decision Date | July 27, 2000 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
K002049 - INVERNESS MEDICAL EARLY PREGNANCY TEST
(FDA 510(k) Clearance)
Jul 2000
Decision
24d
Days
Class 2
Risk
K002049 is an FDA 510(k) clearance for the INVERNESS MEDICAL 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. (Waltham, US). The FDA issued a Cleared decision on July 27, 2000, 24 days after receiving the submission on July 3, 2000.
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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