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510(k) K831055

HEMOGLOBIN ELECTROPHORESIS METH ON THE- by Olympus Corp. — Product Code JBO

K831055 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "HEMOGLOBIN ELECTROPHORESIS METH ON THE-". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code JBO (Test, Euglobulin Lysis), a Class II device regulated under 21 CFR 864.7275. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Euglobulin Lysis
Device Class
Class II
Regulation Number
864.7275
Review Panel
HE
Submission Type

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

FDA data resources