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FDA 510(k)

SYNELISA SM ABS/RNP-SM ABS

K-Number: K930141 · 1993-05-11

ApplicantElias U.S.A., Inc.
Decision Date1993-05-11
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA SM ABS/RNP-SM ABS is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K930141. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA SM ABS/RNP-SM ABS?

SYNELISA SM ABS/RNP-SM ABS is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K930141.

When did SYNELISA SM ABS/RNP-SM ABS receive FDA 510(k) clearance?

SYNELISA SM ABS/RNP-SM ABS received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930141.

Who is the listed applicant for SYNELISA SM ABS/RNP-SM ABS?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNELISA SM ABS/RNP-SM ABS?

The FDA product code for SYNELISA SM ABS/RNP-SM ABS is LKP.

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Other records listing Elias U.S.A., 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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Related Devices (Code: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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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