The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Normal Angiotensin Converting Enzyme Control.
Device ID | K940272 |
510k Number | K940272 |
Device Name: | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
Contact | Dean P Bonderman, Ph.d. |
Correspondent | Dean P Bonderman, Ph.d. ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-12 |
Decision Date | 1994-04-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817869020298 | K940272 | 000 |
00817869020281 | K940272 | 000 |