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FDA 510(k)

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270

K-Number: K884312 · 1989-02-16

ApplicantAtomic Products Corp.
Decision Date1989-02-16
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 is the device name listed in this FDA 510(k) record. The listed applicant is Atomic Products Corp.. It received FDA 510(k) clearance on 1989-02-16 under 510(k) number K884312. 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 ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270?

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 is a medical device that received FDA 510(k) clearance on 1989-02-16. The listed applicant is Atomic Products Corp.. The 510(k) number is K884312.

When did ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 receive FDA 510(k) clearance?

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 received FDA 510(k) clearance on 1989-02-16, under 510(k) number K884312.

Who is the listed applicant for ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270?

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

What is the FDA product code for ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270?

The FDA product code for ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Atomic Products 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.

K915541SPECT TABLE, MODEL #056-760K913055THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900K904187ECONOMY C-ARM TABLE, MODEL # 056-005K904623RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235K900851DIGITAL IMAGE ENHANCEMENT SYSTEMK895799RECTILINEAR SCANNER MODEL #187-270

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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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