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510(k) K880307

ALKALINE PHOSPHATASE REAGENT SET by Tech-Neal Scientific, Inc. — Product Code CJE

K880307 is an FDA 510(k) premarket notification submitted by Tech-Neal Scientific, Inc. for the device "ALKALINE PHOSPHATASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 15, 1988. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Tech-Neal Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1988
Date Received
January 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
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)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880842 — LDH-L REAGENT SET (April 5, 1988)

Other clearances for product code CJE

  • K251074 — Tru Liver Health Test Panel (December 19, 2025)
  • K240468 — Alkaline Phosphatase (October 16, 2024)
  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 (January 25, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)

FDA data resources