The following data is part of a premarket notification filed by Creative Scientific Technology, Inc. with the FDA for Quick Qualitative Calcium Test (quick-cal).
Device ID | K871903 |
510k Number | K871903 |
Device Name: | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) |
Classification | Atomic Absorption, Calcium |
Applicant | CREATIVE SCIENTIFIC TECHNOLOGY, INC. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Contact | Akerkar, Ph.d. |
Correspondent | Akerkar, Ph.d. CREATIVE SCIENTIFIC TECHNOLOGY, INC. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Product Code | JFN |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-15 |
Decision Date | 1987-09-02 |