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FDA 510(k)

AMBERLITE CG50 RESIN, 100-200 MESH

K-Number: K833320 · 1983-12-08

ApplicantBiosan Laboratories, Inc.
Decision Date1983-12-08
Product CodeKEA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMBERLITE CG50 RESIN, 100-200 MESH is the device name listed in this FDA 510(k) record. The listed applicant is Biosan Laboratories, Inc.. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833320. The device is classified under product code KEA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBERLITE CG50 RESIN, 100-200 MESH?

AMBERLITE CG50 RESIN, 100-200 MESH is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Biosan Laboratories, Inc.. The 510(k) number is K833320.

When did AMBERLITE CG50 RESIN, 100-200 MESH receive FDA 510(k) clearance?

AMBERLITE CG50 RESIN, 100-200 MESH received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833320.

Who is the listed applicant for AMBERLITE CG50 RESIN, 100-200 MESH?

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

What is the FDA product code for AMBERLITE CG50 RESIN, 100-200 MESH?

The FDA product code for AMBERLITE CG50 RESIN, 100-200 MESH is KEA.

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Other records listing Biosan Laboratories, 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.

K860642PHOTRON VISUAL FIELD ANALYZERK853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)K832763TOBRAMYCIN REAGENTK833193RADIOIMMUNOASSAY, THYROID STIMU. HORMONEK834023BIO-SCIENCE LABORATORIES T4 REAGENTK833318NORMAL GOAT SERUM

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Related Devices (Code: KEA)

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.

K890997ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)Atlantic Wholesale, Inc.K844948SYVA SOLID PHASE COLUMNSSyva Co.K842028CM-TRISACRYL M DEAE-TRISACRYL MLkb Instruments, Inc.K833319BIO-REX 70 RESIN 100-200 MESH PH6.2Biosan Laboratories, Inc.K831027EXTRELUT QE EXTRACTION COLUMNSEmd Chemicals, Inc.K830918I.E.C COLUMNBerwick Medical Products, Inc.

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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