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FDA 510(k)

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST

K-Number: K882998 · 1988-09-07

ApplicantAmtec Diagnostics International, Inc.
Decision Date1988-09-07
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Amtec Diagnostics International, Inc.. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K882998. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST?

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Amtec Diagnostics International, Inc.. The 510(k) number is K882998.

When did ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST receive FDA 510(k) clearance?

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST received FDA 510(k) clearance on 1988-09-07, under 510(k) number K882998.

Who is the listed applicant for ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST?

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

What is the FDA product code for ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST?

The FDA product code for ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST is DCK.

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Other records listing Amtec Diagnostics International, 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.

K873064AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

Related Devices (Code: DCK)

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.

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Official Source

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