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FDA 510(k)

AMER. HISTO-ID SYS PRIMARY IGM S7920-31

K-Number: K842327 · 1984-08-02

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-08-02
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMER. HISTO-ID SYS PRIMARY IGM S7920-31 is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K842327. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. HISTO-ID SYS PRIMARY IGM S7920-31?

AMER. HISTO-ID SYS PRIMARY IGM S7920-31 is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842327.

When did AMER. HISTO-ID SYS PRIMARY IGM S7920-31 receive FDA 510(k) clearance?

AMER. HISTO-ID SYS PRIMARY IGM S7920-31 received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842327.

Who is the listed applicant for AMER. HISTO-ID SYS PRIMARY IGM S7920-31?

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

What is the FDA product code for AMER. HISTO-ID SYS PRIMARY IGM S7920-31?

The FDA product code for AMER. HISTO-ID SYS PRIMARY IGM S7920-31 is DFT.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: DFT)

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.

K983132IGMAbbott LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, 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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