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510(k) K935138

IMMULITE PROGESTERONE by Diagnostic Products Corp. — Product Code JLS

K935138 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE PROGESTERONE". The FDA issued a decision of Substantially Equivalent on January 11, 1994. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
October 28, 1993
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 Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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