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FDA 510(k)

OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

K-Number: K001632 · 2000-06-19

ApplicantAvl Scientific Corp.
Decision Date2000-06-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 is the device name listed in this FDA 510(k) record. The listed applicant is Avl Scientific Corp.. It received FDA 510(k) clearance on 2000-06-19 under 510(k) number K001632. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009?

OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 is a medical device that received FDA 510(k) clearance on 2000-06-19. The listed applicant is Avl Scientific Corp.. The 510(k) number is K001632.

When did OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 receive FDA 510(k) clearance?

OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 received FDA 510(k) clearance on 2000-06-19, under 510(k) number K001632.

Who is the listed applicant for OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009?

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

What is the FDA product code for OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009?

The FDA product code for OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 is JJY.

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Other records listing Avl Scientific 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.

K000103AVL OPTI R ANALYZERK993837AVL OPTI CRITICAL CARE ANALYZERK990092AVL OMNI MODULAR ANALYZERK984299AVL OPTI CRITICAL CARE ANALYZERK974784AVL OPTI CRITICAL CARE ANALYZERK974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL

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Related Devices (Code: JJY)

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

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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