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510(k) K974572

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 by Chugai Pharmaceuticals Co., Ltd. — Product Code MDK

K974572 is an FDA 510(k) premarket notification submitted by Chugai Pharmaceuticals Co., Ltd. for the device "GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820". The FDA issued a decision of Substantially Equivalent on September 24, 1998. The device falls under product code MDK (Dna-Probe, Reagents, Streptococcal), a Class I device regulated under 21 CFR 866.3740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1998
Date Received
December 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Probe, Reagents, Streptococcal
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances for product code MDK

  • K924715 — GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (March 11, 1994)
  • K915852 — ACCUPACE GROUP A STREPTOCOCCUS ID TEST (April 2, 1992)
  • K904268 — ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (November 13, 1990)

FDA data resources