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510(k) K873759

LABELING CHANGE COAT-A-COUNT METHAQUALONE by Diagnostic Products Corp. — Product Code KXS

K873759 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "LABELING CHANGE COAT-A-COUNT METHAQUALONE". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code KXS (Radioimmunoassay, Methaqualone), a Class II device regulated under 21 CFR 862.3630. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
September 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Methaqualone
Device Class
Class II
Regulation Number
862.3630
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)

Other clearances for product code KXS

  • K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (May 10, 2001)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K955676 — SYNCHRON SYSTEMS METHAQUALONE REAGENT (March 4, 1996)
  • K945187 — ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (April 5, 1995)
  • K940123 — METHAQUALONE ENZYME IMMUNOASSAY (May 3, 1994)
  • K921013 — SYVA EMIT II METHAQUALONE ASSAY (May 13, 1992)
  • K874272 — REVISED LABELING FOR METHAQUALONE TEST KIT (November 13, 1987)
  • K874199 — REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (October 28, 1987)
  • K870935 — COAT-A-COUNT METHAQUALONE TKMQ1 (March 19, 1987)
  • K843605 — EMIT 700 METHAQUALONE ASSAY (October 5, 1984)

FDA data resources