Quick Qualitative Calcium Test (Quick-Cal)

FDA 510(k) K871903 · Creative Scientific Technology, Inc.

Substantially Equivalent

510(k) numberK871903

Submission

Device name
Quick Qualitative Calcium Test (Quick-Cal)
Applicant
Creative Scientific Technology, Inc.
Great Neck, NY, US
Received
May 15, 1987
Decision date
September 2, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JFN – Atomic Absorption, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

Other 510(k)s with product code JFN

510(k)DeviceApplicantDecision
K914510Calcium/Lithium Test Beckman Synchron El-Ise AnalyJFN · Traditional Beckman Instruments, Inc.11/19/1991SE
K770570Calcium/Magnesium AnalyzerJFN · Traditional Beckman Instruments, Inc.06/08/1977SE

Questions and answers

When was Quick Qualitative Calcium Test (Quick-Cal) cleared by the FDA?

Quick Qualitative Calcium Test (Quick-Cal) (K871903) received a 510(k) decision of Substantially Equivalent on September 2, 1987, 110 days after the submission was received.

What is the product code of K871903?

The FDA product code is JFN – Atomic Absorption, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.