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510(k) K870752

SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS by Miles Laboratories, Inc. — Product Code CFJ

K870752 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS". The FDA issued a decision of Substantially Equivalent on Apr 14, 1987. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Miles Laboratories, Inc. has 157 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 14, 1987
Date Received
Feb 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type
510(k) Exempt

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (Apr 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (Apr 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (Dec 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (Oct 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (Sep 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (Aug 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (Jun 29, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (Feb 18, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (Feb 18, 1987)

Other clearances for product code CFJ

  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT… (Oct 2, 2013)
  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (Sep 9, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (Jul 8, 2005)
  • K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (Jan 22, 1998)
  • K973589 — LIQUID LDH-L REAGENT SET (Oct 8, 1997)
  • K970684 — LACTATE DEHYDROGENASE (LD) (May 7, 1997)
  • K971398 — LD-L REAGENT (May 2, 1997)
  • K964912 — LACTATE DEHYDROGENASE (Jan 9, 1997)
  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (Jun 3, 1996)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (Aug 7, 1995)

FDA data resources

Source: FDA 510(k) database entry for K870752. Report a data issue: hello@regdatalab.com.