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FDA 510(k)

THE DDI SERODOT RUBELLA IGG TEST KIT

K-Number: K875368 · 1988-03-23

ApplicantDisease Detection International, Inc.
Decision Date1988-03-23
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE DDI SERODOT RUBELLA IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1988-03-23 under 510(k) number K875368. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DDI SERODOT RUBELLA IGG TEST KIT?

THE DDI SERODOT RUBELLA IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1988-03-23. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K875368.

When did THE DDI SERODOT RUBELLA IGG TEST KIT receive FDA 510(k) clearance?

THE DDI SERODOT RUBELLA IGG TEST KIT received FDA 510(k) clearance on 1988-03-23, under 510(k) number K875368.

Who is the listed applicant for THE DDI SERODOT RUBELLA IGG TEST KIT?

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

What is the FDA product code for THE DDI SERODOT RUBELLA IGG TEST KIT?

The FDA product code for THE DDI SERODOT RUBELLA IGG TEST KIT is LFX.

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Other records listing Disease Detection International, Inc. as applicant

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K943252PRO-STEP LH OVULATION PREDICTION TESTK925303PRO-STEP PT HCGK925125PRO-STEP HCGK911826IMMUNOCARD HCG ONE STEP (I-S) TEST KITK902571MODIFICATION OF SEROCARD RUBELLA IGG TESTK903070SEROCARD HSV IGG ANTIBODY TEST KIT

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche 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.

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