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FDA 510(k)

BIO-REX 70 RESIN 100-200 MESH PH6.2

K-Number: K833319 · 1983-11-03

ApplicantBiosan Laboratories, Inc.
Decision Date1983-11-03
Product CodeKEA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-REX 70 RESIN 100-200 MESH PH6.2 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 1983-11-03 under 510(k) number K833319. 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 BIO-REX 70 RESIN 100-200 MESH PH6.2?

BIO-REX 70 RESIN 100-200 MESH PH6.2 is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Biosan Laboratories, Inc.. The 510(k) number is K833319.

When did BIO-REX 70 RESIN 100-200 MESH PH6.2 receive FDA 510(k) clearance?

BIO-REX 70 RESIN 100-200 MESH PH6.2 received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833319.

Who is the listed applicant for BIO-REX 70 RESIN 100-200 MESH PH6.2?

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 BIO-REX 70 RESIN 100-200 MESH PH6.2?

The FDA product code for BIO-REX 70 RESIN 100-200 MESH PH6.2 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.K833320AMBERLITE CG50 RESIN, 100-200 MESHBiosan 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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