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510(k) K770606

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH by Damon Corp. — Product Code JPA

K770606 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH". The FDA issued a decision of Substantially Equivalent on May 6, 1977. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1977
Date Received
March 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Damon Corp.

  • K874865 — DAMON D.E.T.E.C.T IMAGE ENHANCER (December 23, 1987)
  • K831826 — ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (July 18, 1983)
  • K820686 — LIQUISOL PROGESTERONE RADIOIMMUNO (April 1, 1982)
  • K802661 — LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (December 10, 1980)
  • K790250 — LIQUISOL CORTISOL RIA TEST KIT (April 4, 1979)
  • K782124 — IEC CENTRA-7 CENTRIFUGE MODEL 2362 (February 26, 1979)
  • K781012 — RIA TEST KIT SYS. DAMON KIQUISOL FREE (July 27, 1978)
  • K780207 — LIQUISOL DIGOXIN RIA TEST KIT (February 23, 1978)
  • K770918 — LIQUI SOL T4 RIA TEST KIT (June 17, 1977)
  • K761013 — SPINETTE CENTRIFUGE (November 16, 1976)

Other clearances for product code JPA

  • K253658 — STA Satellite Max® (April 27, 2026)
  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (April 30, 2025)
  • K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (January 15, 2025)
  • K232018 — Citrated: K, KH, RTH, FFH (March 29, 2024)
  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K201440 — ROTEM sigma Thromboelastometry System (July 8, 2022)
  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)

FDA data resources