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510(k) K820686

LIQUISOL PROGESTERONE RADIOIMMUNO by Damon Corp. — Product Code JLS

K820686 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "LIQUISOL PROGESTERONE RADIOIMMUNO". The FDA issued a decision of Substantially Equivalent on April 1, 1982. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1982
Date Received
March 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
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)
  • 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)
  • K770606 — ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (May 6, 1977)
  • K761013 — SPINETTE CENTRIFUGE (November 16, 1976)

Other clearances for product code JLS

  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K973898 — PROGESTERONE ELISA (November 13, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)
  • K964841 — ELECSYS PROGESTERONE ASSAY (March 24, 1997)
  • K965084 — VIDAS PROESTERONE (PRG) (30 409) (January 9, 1997)
  • K955025 — AXSYM PROGESTERONE (March 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (February 5, 1996)
  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)

FDA data resources