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FDA 510(k)

IMMUNO/SLE

K-Number: K872910 · 1987-08-12

ApplicantImmunostics Co., Inc.
Decision Date1987-08-12
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNO/SLE is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872910. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO/SLE?

IMMUNO/SLE is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K872910.

When did IMMUNO/SLE receive FDA 510(k) clearance?

IMMUNO/SLE received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872910.

Who is the listed applicant for IMMUNO/SLE?

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

What is the FDA product code for IMMUNO/SLE?

The FDA product code for IMMUNO/SLE is DHC.

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Other records listing Immunostics Co., 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.

K926569IMMUNO RA UNDILUTEDK902360HEMA-SCREENK894780IMMUNO/ASOK883685IMMUNO/FEBRILE ANTIGENSK863741IMMUNO-CEPT D (BETA-MONOCLONAL)K854619DETECTACULT

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Related Devices (Code: DHC)

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.

K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K930247HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.K930421ELIAS DSDNA ABSElias U.S.A., Inc.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, 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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