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FDA 510(k)

IMMUNOHEMATOLOGICAL SALINE #97139

K-Number: K831200 · 1983-05-09

ApplicantEmd Chemicals, Inc.
Decision Date1983-05-09
Product CodeJCE
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

IMMUNOHEMATOLOGICAL SALINE #97139 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831200. 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 IMMUNOHEMATOLOGICAL SALINE #97139?

IMMUNOHEMATOLOGICAL SALINE #97139 is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K831200.

When did IMMUNOHEMATOLOGICAL SALINE #97139 receive FDA 510(k) clearance?

IMMUNOHEMATOLOGICAL SALINE #97139 received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831200.

Who is the listed applicant for IMMUNOHEMATOLOGICAL SALINE #97139?

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

What is the FDA product code for IMMUNOHEMATOLOGICAL SALINE #97139?

The FDA product code for IMMUNOHEMATOLOGICAL SALINE #97139 is JCE.

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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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.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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