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510(k) K944933

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) by Diagnostic Products Corp. — Product Code JMF

K944933 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code JMF (Radioimmunoassay, Human Placental Lactogen), a Class II device regulated under 21 CFR 862.1585. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
October 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Placental Lactogen
Device Class
Class II
Regulation Number
862.1585
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 JMF

  • K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN (April 4, 1984)
  • K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY (December 28, 1982)
  • K823201 — HUMAN PLACENTAL LACTOGEN KIT (November 29, 1982)
  • K811370 — NATAL-TEC HPL (May 29, 1981)
  • K802454 — GESTE FOLLOW KIT DETERM. OF HPL (November 12, 1980)
  • K791854 — CENTRIA HPL RIA (October 1, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)
  • K771656 — PROLACTIN RIA DIAG. KIT (September 22, 1977)
  • K770659 — RIALYZE HPL (RIA) (May 20, 1977)

FDA data resources