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510(k) K982466

IMMULITE THYROGLOBULIN MODEL LKTY by Diagnostic Products Corp. — Product Code MSW

K982466 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE THYROGLOBULIN MODEL LKTY". The FDA issued a decision of Substantially Equivalent on March 12, 1999. The device falls under product code MSW (System, Test, Thyroglobulin), a Class II device regulated under 21 CFR 866.6010. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1999
Date Received
July 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroglobulin
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
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 MSW

  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K240927 — Access Thyroglobulin (June 28, 2024)
  • K241423 — Access Thyroglobulin (June 7, 2024)
  • K221890 — Elecsys Tg II (September 30, 2023)
  • K220972 — Access Thyroglobulin (September 15, 2023)
  • K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (May 2, 2003)
  • K021057 — BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (September 17, 2002)
  • K002888 — NICHOLS ADVANTAGE THYROGLOB (October 20, 2000)
  • K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (October 19, 2000)
  • K994140 — NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (May 9, 2000)

FDA data resources