Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPOTTEST LOEFFLER METHYLENE BLUE STAIN

K-Number: K843919 · 1984-10-30

ApplicantDifco Laboratories, Inc.
Decision Date1984-10-30
Product CodeKFC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPOTTEST LOEFFLER METHYLENE BLUE STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K843919. The device is classified under product code KFC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTTEST LOEFFLER METHYLENE BLUE STAIN?

SPOTTEST LOEFFLER METHYLENE BLUE STAIN is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K843919.

When did SPOTTEST LOEFFLER METHYLENE BLUE STAIN receive FDA 510(k) clearance?

SPOTTEST LOEFFLER METHYLENE BLUE STAIN received FDA 510(k) clearance on 1984-10-30, under 510(k) number K843919.

Who is the listed applicant for SPOTTEST LOEFFLER METHYLENE BLUE STAIN?

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

What is the FDA product code for SPOTTEST LOEFFLER METHYLENE BLUE STAIN?

The FDA product code for SPOTTEST LOEFFLER METHYLENE BLUE STAIN is KFC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Difco Laboratories, 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.

K971211DISPENS-O-DISC SPARFLOXACINK971120DISPENS-O-DISC (TM) LEVOFLOXACINK963508DISPENS-O-DISC MEROPENEMK961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)K954783DRYSLIDE CARTARRHALISK954784DRYSIDE NEISSERIA

View all 121 devices →

Related Devices (Code: KFC)

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.

K875310RETICULOCYTE STAINSigma Diagnostics, Inc.K842785STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.K842926METHYLENE BLUE STAIN, LOEFFLERE K Ind., Inc.K842743NEW METHYLENE BLUE NE K Ind., Inc.K831502NEPHROLYTEFlaitron Laboratories, Inc.K770792TUBE, STAIN, RETICULOCYTE, LARCCorning Medical & Scientific

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.

↑