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FDA 510(k)

MACRALP(A) ENZYME IMMUNOASSAY KIT

K-Number: K971157 · 1998-04-15

ApplicantStrategic Diagnostics, Inc.
Decision Date1998-04-15
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MACRALP(A) ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Strategic Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-04-15 under 510(k) number K971157. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACRALP(A) ENZYME IMMUNOASSAY KIT?

MACRALP(A) ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1998-04-15. The listed applicant is Strategic Diagnostics, Inc.. The 510(k) number is K971157.

When did MACRALP(A) ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

MACRALP(A) ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1998-04-15, under 510(k) number K971157.

Who is the listed applicant for MACRALP(A) ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for MACRALP(A) ENZYME IMMUNOASSAY KIT?

The FDA product code for MACRALP(A) ENZYME IMMUNOASSAY KIT is JHO.

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Related Devices (Code: JHO)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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