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FDA 510(k)

IMMU-SAL IMMUNOHEMATOLOGICAL SALINE

K-Number: K761303 · 1976-12-30

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1976-12-30
Product CodeKSS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMU-SAL IMMUNOHEMATOLOGICAL SALINE is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761303. The device is classified under product code KSS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMU-SAL IMMUNOHEMATOLOGICAL SALINE?

IMMU-SAL IMMUNOHEMATOLOGICAL SALINE is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K761303.

When did IMMU-SAL IMMUNOHEMATOLOGICAL SALINE receive FDA 510(k) clearance?

IMMU-SAL IMMUNOHEMATOLOGICAL SALINE received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761303.

Who is the listed applicant for IMMU-SAL IMMUNOHEMATOLOGICAL SALINE?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMU-SAL IMMUNOHEMATOLOGICAL SALINE?

The FDA product code for IMMU-SAL IMMUNOHEMATOLOGICAL SALINE is KSS.

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Other records listing Dade, Baxter Travenol Diagnostics, 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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Related Devices (Code: KSS)

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.

K874436FLUID SAMPLING PACKU.S. Mfg. & Management, Inc.K812892S/P SERUM DROPPER PIPETSAmerican DadeK801386PRE-DENT SYSTEM OR PRE-DENT IIPre-Dent SystemK801516PRE-DENT SYSTEM MODIFIEDPre-Dent SystemK800736PRE-DENT SYSTEMPre-Dent System

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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