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510(k) K880676

INORGANIC PHOSPHORUS REAGENT SET by Tech-Neal Scientific, Inc. — Product Code CEO

K880676 is an FDA 510(k) premarket notification submitted by Tech-Neal Scientific, Inc. for the device "INORGANIC PHOSPHORUS REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Tech-Neal Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
February 19, 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-Neal Scientific, Inc.

  • K882256 — MAGNESIUM REAGENT SET (August 8, 1988)
  • K882459 — DIAZO, COLORIMETRIC BILIRUBIN (August 2, 1988)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K881241 — TOTAL BILIRUBIN REAGENT (May 27, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880842 — LDH-L REAGENT SET (April 5, 1988)
  • K880845 — CALCIUM REAGENT SET (April 5, 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