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510(k) K860041

STREP D FLUOR by Bio Spec, Inc. — Product Code GTP

K860041 is an FDA 510(k) premarket notification submitted by Bio Spec, Inc. for the device "STREP D FLUOR". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GTP (Exoenzymes, Multiple, Streptococcal), a Class I device regulated under 21 CFR 866.3720. Bio Spec, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exoenzymes, Multiple, Streptococcal
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Bio Spec, Inc.

  • K860091 — BIO SPEC GRAMAFLUOR TEST KIT (January 21, 1986)
  • K841479 — BIO SPEC STREP-A-FLUOR TEST KIT (April 25, 1984)

Other clearances for product code GTP

  • K833738 — LEAP STREP TEST KIT (December 27, 1983)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

FDA data resources