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510(k) K870250

MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM by Bioclinical Laboratory Services, Inc. — Product Code LYX

K870250 is an FDA 510(k) premarket notification submitted by Bioclinical Laboratory Services, Inc. for the device "MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM". The FDA issued a decision of Substantially Equivalent on April 6, 1987. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Bioclinical Laboratory Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1987
Date Received
January 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Corneal Storage
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Bioclinical Laboratory Services, Inc.

  • K870451 — SKIN GRAFT PRESERVATION MEDIUM (TISSUE) (May 26, 1987)
  • K870249 — MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM (April 6, 1987)
  • K870251 — CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM (April 6, 1987)
  • K864396 — LYMPHOCYTE MAINTENANCE MEDIUM (February 2, 1987)
  • K864740 — BONE MARROW COLLECTION MEDIUM (January 5, 1987)

Other clearances for product code LYX

  • K251320 — XTRA4 (September 11, 2025)
  • K221759 — Cornisol (October 5, 2022)
  • K211786 — Independent Corneal Viewing Chamber (IVC-21) (December 3, 2021)
  • K162013 — Eusol-C (September 15, 2016)
  • K151061 — Cornea Cold (August 6, 2015)
  • K063304 — LIFE4C (December 21, 2007)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)
  • K954548 — THE CHEN MEDIUM (May 20, 1996)
  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 1992)

FDA data resources