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510(k) K772188

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

K772188 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "FSH RIA KIT (125I)". The FDA issued a decision of Substantially Equivalent on December 22, 1977. The device falls under product code FSH (Tray, Surgical, Needle), a Class I device regulated under 21 CFR 878.4800. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

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

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 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)

FDA data resources