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510(k) K882268

ZINC FORMALIN CONCENTRATE by Anatech, Ltd. — Product Code IGG

K882268 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "ZINC FORMALIN CONCENTRATE". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code IGG (Formaldehyde (Formalin, Formol)), 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
June 15, 1988
Date Received
May 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formaldehyde (Formalin, Formol)
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)
  • K881282 — XYLENE (April 5, 1988)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K872498 — HARRIS HEMATOXYLIN (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)
  • K842862 — CB FORMALIN (August 28, 1984)

Other clearances for product code IGG

  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)
  • K811794 — 37% FORMALDEHYDE (July 28, 1981)
  • K802506 — PLEASCENT OR FORMA-SCENT (November 12, 1980)
  • K792707 — PARA-PAK SAF (January 21, 1980)
  • K792705 — PARA-PAK FORMALIN (January 21, 1980)
  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)

FDA data resources