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FDA 510(k)

RAPID IMMUNO-ASSAY SYS

K-Number: K840257 · 1984-04-19

ApplicantApplied Polytechnology, Inc.
Decision Date1984-04-19
Product CodeLLG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RAPID IMMUNO-ASSAY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Applied Polytechnology, Inc.. It received FDA 510(k) clearance on 1984-04-19 under 510(k) number K840257. The device is classified under product code LLG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID IMMUNO-ASSAY SYS?

RAPID IMMUNO-ASSAY SYS is a medical device that received FDA 510(k) clearance on 1984-04-19. The listed applicant is Applied Polytechnology, Inc.. The 510(k) number is K840257.

When did RAPID IMMUNO-ASSAY SYS receive FDA 510(k) clearance?

RAPID IMMUNO-ASSAY SYS received FDA 510(k) clearance on 1984-04-19, under 510(k) number K840257.

Who is the listed applicant for RAPID IMMUNO-ASSAY SYS?

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

What is the FDA product code for RAPID IMMUNO-ASSAY SYS?

The FDA product code for RAPID IMMUNO-ASSAY SYS is LLG.

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Other records listing Applied Polytechnology, Inc. as applicant

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K860483FILTRA-CHECK-UTIK843834BACTERIURIA DETECT. DEVICE APTEK IIK843833BACTERIURIA DETECT DEVICE, MULTI SAMPLERK843359URINE TRANSPORT KITK843316INDOLE SPOT TEST KIT 270-25K834264REVERSE-FLOW SYSTEM

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Related Devices (Code: LLG)

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.

K841465GENERAL DIAGNOSTICS PLATELET ANTIBODYGeneral Diagnostics

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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