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FDA 510(k)

STANDARD IMAGING IVB 1000 WELL CHAMBER

K-Number: K013548 · 2001-11-09

ApplicantStandard Imaging, Inc.
Decision Date2001-11-09
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STANDARD IMAGING IVB 1000 WELL CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Standard Imaging, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K013548. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD IMAGING IVB 1000 WELL CHAMBER?

STANDARD IMAGING IVB 1000 WELL CHAMBER is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K013548.

When did STANDARD IMAGING IVB 1000 WELL CHAMBER receive FDA 510(k) clearance?

STANDARD IMAGING IVB 1000 WELL CHAMBER received FDA 510(k) clearance on 2001-11-09, under 510(k) number K013548.

Who is the listed applicant for STANDARD IMAGING IVB 1000 WELL CHAMBER?

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

What is the FDA product code for STANDARD IMAGING IVB 1000 WELL CHAMBER?

The FDA product code for STANDARD IMAGING IVB 1000 WELL CHAMBER is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Standard Imaging, 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.

K103193DOSEVIEW 3DK082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331K060532HDR 1000 PLUS WELL CHAMBER, MODEL 90008K042733STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMK040688STANDARD IMAGING E.IMRT CALCULATORK002833MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

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Related Devices (Code: KPT)

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.

K192199CRC PC Smart Chamber K1Capintec, Inc.K162394CRC-77tHRCapintec, Inc.K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K042746PET-DOSEComecer S.R.L.

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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