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510(k) K880177

ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT by Tech-Co, Inc. — Product Code CIO

K880177 is an FDA 510(k) premarket notification submitted by Tech-Co, Inc. for the device "ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT". The FDA issued a decision of Substantially Equivalent on April 5, 1988. The device falls under product code CIO (Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Tech-Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
January 15, 1988
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 Tech-Co, Inc.

  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K923376 — VISUAL HCG PREGNANCY TEST (October 1, 1992)
  • K920766 — T4 EIA BEAD ASSAY (April 17, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883683 — HEMOGLOBIN (October 6, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)

Other clearances for product code CIO

  • K860351 — ALKALINE PHOSPHATASE REAGENT SET (February 11, 1986)
  • K855192 — ALKALINE PHOSPHATASE REAGENT SET (January 14, 1986)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • 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