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FDA 510(k)

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA

K-Number: K823087 · 1982-11-18

ApplicantBoehringer Mannheim Corp.
Decision Date1982-11-18
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA 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 1982-11-18 under 510(k) number K823087. The device is classified under product code CKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA?

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA is a medical device that received FDA 510(k) clearance on 1982-11-18. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K823087.

When did BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA receive FDA 510(k) clearance?

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA received FDA 510(k) clearance on 1982-11-18, under 510(k) number K823087.

Who is the listed applicant for BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA?

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 BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA?

The FDA product code for BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA is CKB.

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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: CKB)

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.

K053612DRI-STAT ACID PHOSPHATASE REAGENTBeckman Coulter, Inc.K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.K991010ACPAbbott Diagnostics Mfg., Inc.K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.K963640OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, 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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