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510(k) K894288

PHOSPHORUS TEST ITEM NUMBER 65416 by Em Diagnostic Systems, Inc. — Product Code CED

K894288 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "PHOSPHORUS TEST ITEM NUMBER 65416". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1989
Date Received
June 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Device Class
Class I
Regulation Number
862.1520
Review Panel
CH
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code CED

  • K840151 — EKTACHEM CLINICAL CHEM. SLIDES (March 22, 1984)
  • K833710 — BTC URINE LH ASSAY (January 30, 1984)
  • K820832 — PHOSPHORUS IL (April 15, 1982)
  • K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE (October 2, 1981)
  • K811864 — SIGMA PROCEDURE 265-UV (July 31, 1981)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K802420 — CENTRIFICHEM INORGANIC PHOSPHORUS (October 31, 1980)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)

FDA data resources