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510(k) K823680

COAT-A-COUNT MORPHINE KIT & COMPONENTS by Diagnostic Products Corp. — Product Code DDE

K823680 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "COAT-A-COUNT MORPHINE KIT & COMPONENTS". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code DDE (Carbonic Anhydrase C, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5200. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
December 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbonic Anhydrase C, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5200
Review Panel
HE
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 DDE

  • K902055 — TENONE(TM) OPIATES CATALOG: VKSO1,4 (July 10, 1990)
  • K820900 — EMIT URINE METHADONE ASSAY #3E319 (April 26, 1982)

FDA data resources