The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Spectrum Urine/serum Pregnancy Test Device.
| Device ID | K041946 |
| 510k Number | K041946 |
| Device Name: | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung, Ph.d. |
| Correspondent | Edward Tung, Ph.d. ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-08-16 |
| Summary: | summary |