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510(k) K812434

DIAGNOSTIC KITS & KIT COMPONENTS by Diagnostica, Inc. — Product Code LHT

K812434 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "DIAGNOSTIC KITS & KIT COMPONENTS". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 25, 1981
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 Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

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)
  • K820531 — ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (April 14, 1982)
  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812374 — ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (September 9, 1981)
  • K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)

FDA data resources