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510(k) K780982

KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT by Cis Radiopharmaceuticals, Inc. — Product Code DDR

K780982 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
Submission Type

Other clearances by Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 1976)

Other clearances for product code DDR

  • K231832 — Access Myoglobin (September 18, 2023)
  • K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (June 7, 2013)
  • K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (October 3, 2012)
  • K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (October 16, 2009)
  • K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CA (February 20, 2009)
  • K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (July 21, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K042982 — QUANTEX MYOGLOBIN (December 22, 2004)
  • K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI (November 5, 2003)
  • K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 (June 28, 2002)

FDA data resources