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FDA 510(k)

PHYSIOLOGIC SALINE (0.85%)

K-Number: K761174 · 1977-01-10

ApplicantBio/Data Corp.
Decision Date1977-01-10
Product CodeJCE
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PHYSIOLOGIC SALINE (0.85%) is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1977-01-10 under 510(k) number K761174. 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 PHYSIOLOGIC SALINE (0.85%)?

PHYSIOLOGIC SALINE (0.85%) is a medical device that received FDA 510(k) clearance on 1977-01-10. The listed applicant is Bio/Data Corp.. The 510(k) number is K761174.

When did PHYSIOLOGIC SALINE (0.85%) receive FDA 510(k) clearance?

PHYSIOLOGIC SALINE (0.85%) received FDA 510(k) clearance on 1977-01-10, under 510(k) number K761174.

Who is the listed applicant for PHYSIOLOGIC SALINE (0.85%)?

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

What is the FDA product code for PHYSIOLOGIC SALINE (0.85%)?

The FDA product code for PHYSIOLOGIC SALINE (0.85%) is JCE.

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Other records listing Bio/Data 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK943153MICROSAMPLE COAGULATION ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA

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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.

K842722BUFFERED SALINEE K Ind., Inc.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.

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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