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FDA 510(k)

ELISA-DPXA SSA KIT

K-Number: K924945 · 1993-05-19

ApplicantAdvanced Biological Products, Inc.
Decision Date1993-05-19
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELISA-DPXA SSA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biological Products, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K924945. 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 ELISA-DPXA SSA KIT?

ELISA-DPXA SSA KIT is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Advanced Biological Products, Inc.. The 510(k) number is K924945.

When did ELISA-DPXA SSA KIT receive FDA 510(k) clearance?

ELISA-DPXA SSA KIT received FDA 510(k) clearance on 1993-05-19, under 510(k) number K924945.

Who is the listed applicant for ELISA-DPXA SSA KIT?

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

What is the FDA product code for ELISA-DPXA SSA KIT?

The FDA product code for ELISA-DPXA SSA KIT is LLL.

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Other records listing Advanced Biological Products, 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.

K924952ELISA-DOXA COMBI-6K924949ELISA-DOXA SCL-70K924946ELISA-DOXA SSBK924948ELISA-DOXA SM/RNPK924947ELISA-DOXA SMK924951ELISA-DOXA COMBI-4

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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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