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510(k) K820531

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT by Meridian Diagnostics, Inc. — Product Code LHT

K820531 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "ENDO-STAPH TEICHOIC ACID ANTIBODY KIT". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Somatic Antigens
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

Other clearances by Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

Other clearances for product code LHT

  • K874303 — STAPHYLASE TEST (November 6, 1987)
  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (April 14, 1982)
  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)
  • K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812374 — ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (September 9, 1981)

FDA data resources