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510(k) K832791

SERAYZER ALT/SGPT REAGENT STRIPS by Miles Laboratories, Inc. — Product Code CKC

K832791 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "SERAYZER ALT/SGPT REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code CKC (Vanillin Pyruvate, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vanillin Pyruvate, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code CKC

  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)

FDA data resources