The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Pcp One-step Phencyclidine Test Strip, Acon Pcp One-step Phencyclidine Test Device.
| Device ID | K011730 |
| 510k Number | K011730 |
| Device Name: | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-05 |
| Decision Date | 2001-08-09 |
| Summary: | summary |