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510(k) K954755

COAT-A-COUNT DIRECT ANDROSTENEDIONE by Diagnostic Products Corp. — Product Code CIZ

K954755 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "COAT-A-COUNT DIRECT ANDROSTENEDIONE". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code CIZ (Radioimmunoassay, Androstenedione), a Class I device regulated under 21 CFR 862.1075. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Androstenedione
Device Class
Class I
Regulation Number
862.1075
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 CIZ

  • K963002 — ACTIVE ANDROSTENEDIONE EIA (August 16, 1996)
  • K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE (January 10, 1994)
  • K860559 — ANDROSTENEDIONE 125I KIT BY RIA (March 14, 1986)
  • K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200) (January 22, 1986)
  • K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (December 13, 1985)
  • K844398 — COAT-A-COUNT ANDROSTENEDIONE RIA KIT (December 10, 1984)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)

FDA data resources