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FDA 510(k)

BUFFERED SALINE

K-Number: K842722 · 1984-09-11

ApplicantE K Ind., Inc.
Decision Date1984-09-11
Product CodeJCE
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

BUFFERED SALINE is the device name listed in this FDA 510(k) record. The listed applicant is E K Ind., Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K842722. The device is classified under product code JCE. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUFFERED SALINE?

BUFFERED SALINE is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is E K Ind., Inc.. The 510(k) number is K842722.

When did BUFFERED SALINE receive FDA 510(k) clearance?

BUFFERED SALINE received FDA 510(k) clearance on 1984-09-11, under 510(k) number K842722.

Who is the listed applicant for BUFFERED SALINE?

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

What is the FDA product code for BUFFERED SALINE?

The FDA product code for BUFFERED SALINE is JCE.

Related Clinical Trials

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.

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Other records listing E K Ind., 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.

K842931DRABKIN REAGENTK842938ACETIC ACID 1% V/VK842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%K842937ACETIC ACID 2% V/VK842935ACETIC ACID, 5% V/VK842936ACETIC ACID, 3% V/V

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Related Devices (Code: JCE)

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.

K831200IMMUNOHEMATOLOGICAL SALINE #97139Emd Chemicals, Inc.K801506CERTIFIED BLOOD BANK SALINENobel Scientific Industries, Inc.K792101COUITER/CMS ISOTONIC BLOOD BANK SALINECoulter Electronics, Inc.K761183LYSING AGENT AFCentral Labs. Assoc. MD PathologistsK761170BARBITAL SALINE BUFFERBio/Data Corp.K761174PHYSIOLOGIC SALINE (0.85%)Bio/Data Corp.

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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