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510(k) K822558

LSM AGAR by Granite Diagnostics, Inc. — Product Code JWX

K822558 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "LSM AGAR". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Granite Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Staphylococcus Aureus
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Granite Diagnostics, Inc.

  • K850970 — BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (March 29, 1985)
  • K850969 — INHIBITORY MOLD AGAR PLATE (March 29, 1985)
  • K833254 — STREPTOCOCCUS ID TRIPLATE SYSTEM (October 28, 1983)
  • K832365 — TCBS AGAR (September 1, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)
  • K830252 — DIPCHEX DIP-SLIDE CULTURE SYS (March 7, 1983)
  • K830251 — CAMPY BLOOD AGAR PLATE (February 28, 1983)
  • K823248 — SCHAEDLER AGARS (December 3, 1982)
  • K823139 — SMITH'S MEDIUM (December 3, 1982)
  • K823122 — LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (December 3, 1982)

Other clearances for product code JWX

  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (September 8, 1997)
  • K964315 — REMEL STAPH LATEX KIT (February 7, 1997)
  • K945538 — STAPHAUREX PLUS(TM) (June 1, 1995)
  • K926173 — STAPH-A-LEX(TM) SYSTEM (August 10, 1993)
  • K923212 — SLIDEX STAPH-KIT (September 28, 1992)
  • K905617 — VISI-STAPH (March 29, 1991)
  • K902259 — AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (June 18, 1990)
  • K874019 — STAPHSLIDE (October 28, 1987)
  • K854278 — NEG COMBO BREAKPOINT PANEL POS COMBO (March 4, 1986)

FDA data resources