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)

GRAM SWAB

K-Number: K970834 · 1997-04-17

ApplicantRemel, Inc.
Decision Date1997-04-17
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM SWAB is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K970834. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM SWAB?

GRAM SWAB is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Remel, Inc.. The 510(k) number is K970834.

When did GRAM SWAB receive FDA 510(k) clearance?

GRAM SWAB received FDA 510(k) clearance on 1997-04-17, under 510(k) number K970834.

Who is the listed applicant for GRAM SWAB?

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

What is the FDA product code for GRAM SWAB?

The FDA product code for GRAM SWAB is JTO.

Other records listing Remel, 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.

K162620Remel Spectra ESBLK131804REMEL XPECT FLU A&BK092407REMEL SPECTRA MRSAK072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

View all 17 devices →

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.K961191COLISCREENHardy Diagnostics

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.

↑