Snap(R) Campylobacter Culture Ident Diagnostic Kit

FDA 510(k) K874544 · Molecular Biosystems, Inc.

Substantially Equivalent

510(k) numberK874544

Submission

Device name
Snap(R) Campylobacter Culture Ident Diagnostic Kit
Applicant
Molecular Biosystems, Inc.
San Diego, CA, US
Received
November 3, 1987
Decision date
August 12, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LGO – Test, Leukocyte Typing
Device class
Class I (low risk)
Regulation
21 CFR 864.7675
Specialty
Hematology

Other 510(k)s with product code LGO

510(k)DeviceApplicantDecision
K894947Platelia Toxo Igg KitLGO · Traditional Kallestad Diag, A Div. of Erbamont, Inc.03/23/1990SE
K791118Hla Control SeraLGO · Traditional Calbiochem-Behring Corp.08/03/1979SE
K761009Lymphocyte Typing, Positive ControlLGO · Traditional Hyland Therapeutic Div., Travenol Laboratories04/06/1977SE
K761008Lymphocyte Typing, Negative ControlLGO · Traditional Hyland Therapeutic Div., Travenol Laboratories04/06/1977SE

More from Hyland Therapeutic Div., Travenol Laboratories

510(k)DeviceDecision
K873670Snap Campylobactor Diagnostic KitLQO · Traditional 06/08/1988SE
K873565Snap(R) Rotavirus Diagnostic KitLIO · Traditional 05/13/1988SE
K873932The Extractor(Tm)DKO · Traditional 11/20/1987SE

Questions and answers

When was Snap(R) Campylobacter Culture Ident Diagnostic Kit cleared by the FDA?

Snap(R) Campylobacter Culture Ident Diagnostic Kit (K874544) received a 510(k) decision of Substantially Equivalent on August 12, 1988, 283 days after the submission was received.

What is the product code of K874544?

The FDA product code is LGO – Test, Leukocyte Typing, a Class I (low risk) device regulated under 21 CFR 864.7675.