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510(k) K842709

IMMUSTAPH LATEX AGGLUTINATION KIT by Immucell Corp. — Product Code LHJ

K842709 is an FDA 510(k) premarket notification submitted by Immucell Corp. for the device "IMMUSTAPH LATEX AGGLUTINATION KIT". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code LHJ (Staphylococcus Aureus Protein A Insoluble), a Class I device regulated under 21 CFR 866.3700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
July 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Protein A Insoluble
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

Other clearances for product code LHJ

  • K940557 — STAPHYTECT-OD (July 28, 1994)
  • K812181 — STAPHYLOCOCCAL PROTEIN A INSOLUBLE (August 25, 1981)

FDA data resources