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FDA 510(k)

GRAM STAIN CONTROL SLIDE

K-Number: K890718 · 1989-03-16

ApplicantScientific Device Laboratory, Inc.
Decision Date1989-03-16
Product CodeLJG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM STAIN CONTROL SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Laboratory, Inc.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K890718. The device is classified under product code LJG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM STAIN CONTROL SLIDE?

GRAM STAIN CONTROL SLIDE is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Scientific Device Laboratory, Inc.. The 510(k) number is K890718.

When did GRAM STAIN CONTROL SLIDE receive FDA 510(k) clearance?

GRAM STAIN CONTROL SLIDE received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890718.

Who is the listed applicant for GRAM STAIN CONTROL SLIDE?

The FDA 510(k) record lists Scientific Device Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM STAIN CONTROL SLIDE?

The FDA product code for GRAM STAIN CONTROL SLIDE is LJG.

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Other records listing Scientific Device Laboratory, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935316PARASAFE(R) FIXATIVEK924893MICROSPORIDIUM CONTROL SLIDEK911059TURBIDOMETRIC STANDARDK895848PRESSURE STEAM STERILIZERSK890670CRYPTOSPORIDIUM CONTROL SLIDEK884069SNAP N' STAIN IODINE STAIN

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Related Devices (Code: LJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890616BION DIRECT IDENTIFICATION CONTROL SLIDEBion Ent., Ltd.K883569HISTO-CHECK GRAM NEGATIVE SLIDESVal Tech Diagnostics, Inc.K883568HISTO-CHECK ACID FAST SLIDESVal Tech Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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