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510(k) K802451

BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. by Syn-Kit, Inc. — Product Code JHQ

K802451 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code JHQ (Nephelometric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
October 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

FDA data resources