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FDA 510(k)

ELECSYS PSA (ON ELECSYS 1010)

K-Number: K974189 · 1998-01-06

ApplicantBoehringer Mannheim Corp.
Decision Date1998-01-06
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS PSA (ON ELECSYS 1010) is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-01-06 under 510(k) number K974189. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS PSA (ON ELECSYS 1010)?

ELECSYS PSA (ON ELECSYS 1010) is a medical device that received FDA 510(k) clearance on 1998-01-06. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K974189.

When did ELECSYS PSA (ON ELECSYS 1010) receive FDA 510(k) clearance?

ELECSYS PSA (ON ELECSYS 1010) received FDA 510(k) clearance on 1998-01-06, under 510(k) number K974189.

Who is the listed applicant for ELECSYS PSA (ON ELECSYS 1010)?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS PSA (ON ELECSYS 1010)?

The FDA product code for ELECSYS PSA (ON ELECSYS 1010) is LTJ.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: LTJ)

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.

K251630Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc.K162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc.K124056FREND PSA PLUS (REAGENT CARTRIDGE)Nanoentek, Inc.K031343TPSA FLEX REAGENT CARTRIDGEDade Behring, Inc.K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBayer Corp.K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.

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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