Formical

FDA 510(k) K821443 · Lerner Laboratories, Inc.

Substantially Equivalent

510(k) numberK821443

Submission

Device name
Formical
Applicant
Lerner Laboratories, Inc.
Mchenry, IL, US
Received
May 14, 1982
Decision date
June 2, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDX – Solution, Decalcifier, Acid Containing
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code KDX

510(k)DeviceApplicantDecision
K872625Decalcifying SolutionKDX · Traditional Stephens Scientific08/06/1987SE
K850636Simutaneous Fixation & Decalcifying Solution Cal-EKDX · Traditional Fisher Scientific Co., LLC03/20/1985SE
K842726Decalcifier SolutionKDX · Traditional E K Ind., Inc.08/03/1984SE
K841488Decalcifier IKDX · Traditional Surgipath Medical Industries, Inc.05/02/1984SE
K822036Volu-Sol DecalciferKDX · Traditional Volu Sol Medical Industries08/03/1982SE
K811801Cal-RiteKDX · Traditional Richard-Allan Medical Ind., Inc.07/28/1981SE
K810836Decalcifier IIKDX · Traditional Surgipath04/23/1981SE

More from Surgipath

510(k)DeviceDecision
K854083Xylene Substitute MontantKEM · Traditional 10/22/1985SE
K853694Xylene SubstituteKEM · Traditional 10/22/1985SE
K761001Pap-Tray II (Catalog #C600-2)LEA · Traditional 12/06/1976SE
K761000Pap-Tray I (Catalog #C600-1)LEA · Traditional 12/06/1976SE

Questions and answers

When was Formical cleared by the FDA?

Formical (K821443) received a 510(k) decision of Substantially Equivalent on June 2, 1982, 19 days after the submission was received.

What is the product code of K821443?

The FDA product code is KDX – Solution, Decalcifier, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.