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510(k) K881171

PHOSPHORUS (INORGANIC) by Tech-Co, Inc. — Product Code CEO

K881171 is an FDA 510(k) premarket notification submitted by Tech-Co, Inc. for the device "PHOSPHORUS (INORGANIC)". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Tech-Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
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)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)

Other clearances for product code CEO

  • K100263 — ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (May 6, 2011)
  • K072141 — S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (June 24, 2008)
  • K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (August 18, 2004)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (March 7, 2003)
  • K022312 — PICCOLO PHOSPHORUS TEST SYSTEM (September 5, 2002)
  • K013095 — WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (November 16, 2001)
  • K003912 — PHOSPHORUS REAGENT (February 21, 2001)
  • K003012 — RAICHEM PHOSPORUS REAGENT (October 25, 2000)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)

FDA data resources