The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest Hcg 2 Iu/ml Test Kit.
| Device ID | K001215 |
| 510k Number | K001215 |
| Device Name: | DBEST HCG 2 IU/ML TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | K.c. Yee |
| Correspondent | K.c. Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-14 |
| Decision Date | 2000-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863545000306 | K001215 | 000 |