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FDA 510(k)

ELISA-DOXA COMBI-4

K-Number: K924951 · 1993-05-19

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

Device Summary

ELISA-DOXA COMBI-4 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 K924951. 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-DOXA COMBI-4?

ELISA-DOXA COMBI-4 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 K924951.

When did ELISA-DOXA COMBI-4 receive FDA 510(k) clearance?

ELISA-DOXA COMBI-4 received FDA 510(k) clearance on 1993-05-19, under 510(k) number K924951.

Who is the listed applicant for ELISA-DOXA COMBI-4?

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-DOXA COMBI-4?

The FDA product code for ELISA-DOXA COMBI-4 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.

K924945ELISA-DPXA SSA KITK924952ELISA-DOXA COMBI-6K924949ELISA-DOXA SCL-70K924946ELISA-DOXA SSBK924948ELISA-DOXA SM/RNPK924947ELISA-DOXA SM

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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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