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510(k) K772188

FSH RIA KIT (125I) by Diagnostic Products Corp. — Product Code FSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
November 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Needle
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
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  • 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 FSH

  • K884876 — S 4 INSTRUMENT STAND (December 15, 1988)
  • K883578 — S 21 INSTRUMENT STAND (September 13, 1988)
  • K821921 — STAND, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K813338 — BIOPSY NEEDLES & TRAYS (January 28, 1982)
  • K813337 — SKINNY CHIBA NEEDLE & TRAY (January 28, 1982)
  • K813335 — PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (January 8, 1982)
  • K780759 — MODEL 902 STAND (May 19, 1978)