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510(k) K860642

PHOTRON VISUAL FIELD ANALYZER by Biosan Laboratories, Inc. — Product Code HOM

K860642 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "PHOTRON VISUAL FIELD ANALYZER". The FDA issued a decision of Substantially Equivalent on April 15, 1986. The device falls under product code HOM (Screen, Tangent, Ac-Powered (Campimeter)), a Class I device regulated under 21 CFR 886.1810. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1986
Date Received
February 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Tangent, Ac-Powered (Campimeter)
Device Class
Class I
Regulation Number
886.1810
Review Panel
OP
Submission Type

Other clearances by Biosan Laboratories, Inc.

  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)
  • K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (February 4, 1984)
  • K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT (January 24, 1984)
  • K833318 — NORMAL GOAT SERUM (January 3, 1984)
  • K833192 — NORMAL URINE CONTROL (December 8, 1983)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833191 — ABNORMAL URINE CONTROL (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)

FDA data resources