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510(k) K842516

SANDARE ACID PHOSPHATASE PROCEDURE by Sandare Chemical Co., Inc. — Product Code CJR

K842516 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "SANDARE ACID PHOSPHATASE PROCEDURE". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code CJR (Acid Phosphatase, Thymol Blue Monophosphate), a Class II device regulated under 21 CFR 862.1020. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Thymol Blue Monophosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

Other clearances by Sandare Chemical Co., Inc.

  • K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (September 29, 1987)
  • K862556 — SANDARE GLYCOHEMOGLOBIN PROCEDURE (August 8, 1986)
  • K860684 — SANDARE BCG ALBUMIN PROCEDURE (March 17, 1986)
  • K851395 — SANDARE IRON-BINDING CAPACITY PROCEDURE (May 7, 1985)
  • K851394 — SANDARE IRON PROCEDURE (April 30, 1985)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K833898 — TRI-LEVEL BILIRUBIN CONTROLS (January 13, 1984)
  • K832942 — TOTAL & DIRECT BILIRUBIN PROCEDURES (November 7, 1983)
  • K832632 — ALBUMIN PROCEDURE BCP (September 12, 1983)
  • K832183 — SANDARE CALCIUM PROCEDURE (August 24, 1983)

Other clearances for product code CJR

  • K760161 — TEST, ACID PHOSPHATASE (July 20, 1976)

FDA data resources