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510(k) K855192

ALKALINE PHOSPHATASE REAGENT SET by Technostics Intl. — Product Code CIO

K855192 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "ALKALINE PHOSPHATASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 14, 1986. The device falls under product code CIO (Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Technostics Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1986
Date Received
December 26, 1985
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 Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860109 — ENZYMATIC UREA NITROGEN REAGENT SET (February 6, 1986)
  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET (January 21, 1986)
  • K855154 — INORGANIC PHOSPHORUS REAGENT SET (January 14, 1986)
  • K855193 — CREATININE REAGENT SET (January 14, 1986)

Other clearances for product code CIO

  • K880177 — ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (April 5, 1988)
  • K860351 — ALKALINE PHOSPHATASE REAGENT SET (February 11, 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