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510(k) K844498

SANDARE ALKALINE PHOSPHATASE PROCEDURE by Sandare Chemical Co., Inc. — Product Code CIO

K844498 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "SANDARE ALKALINE PHOSPHATASE PROCEDURE". The FDA issued a decision of Substantially Equivalent on December 10, 1984. The device falls under product code CIO (Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1984
Date Received
November 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
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)
  • K842516 — SANDARE ACID PHOSPHATASE PROCEDURE (August 17, 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 CIO

  • K880177 — ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (April 5, 1988)
  • K860351 — ALKALINE PHOSPHATASE REAGENT SET (February 11, 1986)
  • K855192 — ALKALINE PHOSPHATASE REAGENT SET (January 14, 1986)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K841064 — ALKALINE PHOSPHOTASE REAGENT SET (May 1, 1984)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)
  • K821200 — ALKALINE PHOSPHOTASE REAGENT SET (July 13, 1982)
  • K781324 — ALP TEST (August 31, 1978)
  • K772257 — ALKALINE PHOSPHATASE TEST SET (December 22, 1977)
  • K770453 — PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (May 3, 1977)

FDA data resources