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510(k) K800189

BOVINE ALBUMIN 22% & 30% SOLUTIONS by Gotham Biologics, Inc. — Product Code KSG

K800189 is an FDA 510(k) premarket notification submitted by Gotham Biologics, Inc. for the device "BOVINE ALBUMIN 22% & 30% SOLUTIONS". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code KSG (Media, Potentiating For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9600. Gotham Biologics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 29, 1980
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 Gotham Biologics, Inc.

  • K800239 — RH-HR NEGATIVE CONTROL REAGENT (February 21, 1980)

Other clearances for product code KSG

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K800943 — PENTEX BOVINE ALBUMIN 30% SOLUTION (May 8, 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