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FDA 510(k)

HISTONE REACTIVE ANA

K-Number: K883232 · 1988-09-07

ApplicantVal Tech Diagnostics, Inc.
Decision Date1988-09-07
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HISTONE REACTIVE ANA is the device name listed in this FDA 510(k) record. The listed applicant is Val Tech Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K883232. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTONE REACTIVE ANA?

HISTONE REACTIVE ANA is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Val Tech Diagnostics, Inc.. The 510(k) number is K883232.

When did HISTONE REACTIVE ANA receive FDA 510(k) clearance?

HISTONE REACTIVE ANA received FDA 510(k) clearance on 1988-09-07, under 510(k) number K883232.

Who is the listed applicant for HISTONE REACTIVE ANA?

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

What is the FDA product code for HISTONE REACTIVE ANA?

The FDA product code for HISTONE REACTIVE ANA is LLL.

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Other records listing Val Tech Diagnostics, 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.

K883571HISTO-CHECK PARASITIC CONTROL SLIDESK883568HISTO-CHECK ACID FAST SLIDESK883569HISTO-CHECK GRAM NEGATIVE SLIDESK883570HISTO-CHECK FUNGAL CONTROL SLIDESK883567HISTO-CHECK LEGIONELLA CONTROL SLIDESK883684HERPES VIRUS CONTROL SLIDES

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Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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