510(k) K901276

HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL by Diagnostic Products Corp. — Product Code DIT

K901276 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code DIT (Thin Layer Chromatography, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 26, 1990
Date Received: March 19, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Thin Layer Chromatography, Amphetamine
Device Class: Class II
Regulation Number: 862.3100
Review Panel: TX
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)

510(k) K901276

Clearance Details

Device Classification

Other clearances by Diagnostic Products Corp.

Other clearances for product code DIT

FDA data resources