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510(k) K842862

CB FORMALIN by Anatech, Ltd. — Product Code IGE

K842862 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "CB FORMALIN". The FDA issued a decision of Substantially Equivalent on August 28, 1984. The device falls under product code IGE (Solution, Formalin Ammonium Bromide), a Class I device regulated under 21 CFR 864.4010. Anatech, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1984
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Formalin Ammonium Bromide
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Anatech, Ltd.

  • K882874 — ZINC FORMALIN (July 28, 1988)
  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K881282 — XYLENE (April 5, 1988)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K872499 — ANATECH HEMATOXYLIN-NORMAL STRENGTH (July 9, 1987)
  • K870852 — NBF 10% NEUTRAL BUFFERED FORMALIN (March 31, 1987)
  • K842940 — CBA FORMALIN (August 28, 1984)

Other clearances for product code IGE

  • K950560 — SALINE SOLUTINE, STERILE (May 30, 1995)

FDA data resources