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510(k) K860924

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT by Monoclonal Antibodies, Inc. — Product Code JLS

K860924 is an FDA 510(k) premarket notification submitted by Monoclonal Antibodies, Inc. for the device "RAMP PROGESTURINE PDG ASSAY--48 TEST KIT". The FDA issued a decision of Substantially Equivalent on July 2, 1986. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Monoclonal Antibodies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1986
Date Received
March 11, 1986
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 Monoclonal Antibodies, Inc.

  • K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (February 16, 1988)
  • K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (July 27, 1987)
  • K863744 — HCG CONTROL KIT (November 5, 1986)
  • K854611 — RAMP URINE HCG ASSAY (December 30, 1985)
  • K850730 — MODEL SERUM HCG ASSAY (April 2, 1985)
  • K850480 — OVU STICK SELF-TEST -MODIFICATION (March 5, 1985)
  • K843284 — OVUSTICK SELF-TEST (December 11, 1984)
  • K840738 — PLUS URINE HCG ASSAY (April 19, 1984)
  • K840412 — OVU STICK URINE HLH KIT (April 13, 1984)
  • K833504 — PREGNASTICK URINE HCG KIT (January 9, 1984)

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