Sandare Calcium Procedure

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832183 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sandare Uric Acid Procedure

  Class I

  FDA 510(k) K812313 Active Cleared 1 Sep 1981

• Sandare Chloride Procedure

  Class II

  FDA 510(k) K792531 Active Cleared 11 Jan 1980

• Sandare Hemoglobin Controls

  Class II

  FDA 510(k) K792209 Active Cleared 4 Dec 1979

• Total Protein Procedure

  Class II

  FDA 510(k) K832169 Active Cleared 16 Aug 1983

• Sandare Nitroprusside Test Procedure

  Class I

  FDA 510(k) K810514 Active Cleared 4 Mar 1981

• Tri-Level Bilirubin Controls

  Class I

  FDA 510(k) K833898 Active Cleared 13 Jan 1984

See all devices from Sandare Chemical Co., Inc. →

• What is the Sandare Calcium Procedure used for?

  The Sandare Calcium Procedure is a device used in clinical chemistry for the measurement of calcium in clinical laboratory settings, based on the cresolphthalein complexone method.

• Who manufactures the Sandare Calcium Procedure and where are they located?

  The Sandare Calcium Procedure is manufactured by Sandare Chemical Co., Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.

• What regulatory pathway was used for the Sandare Calcium Procedure and when was it cleared?

  The Sandare Calcium Procedure received FDA 510(k) clearance through a traditional submission (K832183) on August 24, 1983, and was found substantially equivalent to a predicate device.

• How is the Sandare Calcium Procedure classified and what regulation number applies to it?

  The Sandare Calcium Procedure is classified as a Class II medical device under regulation number 862.1145, with product code CIC and advisory committee designation CH (Clinical Chemistry).

• Is the Sandare Calcium Procedure intended for use outside of clinical laboratories?

  No, the device is specifically intended for use in clinical laboratory settings for the measurement of calcium, as stated in its description and authorization details.