Home / 510(k) Clearances / K812372

510(k) K812372

GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF by Dutchland Laboratories, Inc. — Product Code LHT

K812372 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF". The FDA issued a decision of Substantially Equivalent on September 9, 1981. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 20, 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 Dutchland Laboratories, Inc.

  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K820928 — EBS POWDER (April 21, 1982)

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)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 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)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)

FDA data resources