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510(k) K812222

EM-X by Biological Corp. of America — Product Code KSG

K812222 is an FDA 510(k) premarket notification submitted by Biological Corp. of America for the device "EM-X". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code KSG (Media, Potentiating For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9600. Biological Corp. of America has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Potentiating For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9600
Review Panel
HE
Submission Type

Other clearances by Biological Corp. of America

  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K781397 — EM-V (September 14, 1978)
  • K760162 — HEMATOLOGY CONTROL (August 4, 1976)

Other clearances for product code KSG

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K800943 — PENTEX BOVINE ALBUMIN 30% SOLUTION (May 8, 1980)
  • K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS (February 13, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790973 — LO-ION (June 15, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790498 — LISS REAGENT (April 3, 1979)
  • K781435 — ORTHO LOW IONIC SOLUTION (September 14, 1978)
  • K781397 — EM-V (September 14, 1978)

FDA data resources