FDA 510(k)

BIO-CHECK GRAM STAIN CONTROL

K-Number: K821660 · 1982-06-25

Decision Date1982-06-25

Product CodeJTR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BIO-CHECK GRAM STAIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821660. The device is classified under product code JTR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CHECK GRAM STAIN CONTROL?

BIO-CHECK GRAM STAIN CONTROL is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is American Scientific Products. The 510(k) number is K821660.

When did BIO-CHECK GRAM STAIN CONTROL receive FDA 510(k) clearance?

BIO-CHECK GRAM STAIN CONTROL received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821660.

Who is the listed applicant for BIO-CHECK GRAM STAIN CONTROL?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CHECK GRAM STAIN CONTROL?

The FDA product code for BIO-CHECK GRAM STAIN CONTROL is JTR.

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Other records listing American Scientific Products as applicant

K864824INFECTIOUS TISSUE KIT K844042BLOOD DILUTION VIAL K831634GLUCOSE REAGENT B6360-11 K831625UREA NITROGEN-BUN-REAGENTS B6360-12 K831626UREA NITROGEN-BUN-REAGENTS B6370-11A K831628CREATININE REAGENTS B6370-13

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Related Devices (Code: JTR)

K871121PROTECT T.M.Pro-Lab, Inc.K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDETrend Scientific, Inc.K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics K855198INDI KWIK (TM) CO/TWO KITMicro-Bio-Logics K842579B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONSBiological & Environmental Control Laboratories K842129LYFO-DISK MICROORGANISMSMicro-Bio-Logics

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.