The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Quik-check Home Pregnancy Test.
| Device ID | K012215 |
| 510k Number | K012215 |
| Device Name: | QUIK-CHECK HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00430000702077 | K012215 | 000 |
| 10681131175989 | K012215 | 000 |
| 00751774975949 | K012215 | 000 |
| 10761706168490 | K012215 | 000 |
| 10041220646477 | K012215 | 000 |