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FDA 510(k)

PBS FOR FA (46-991-49)

K-Number: K781391 · 1978-08-21

ApplicantFlow Laboratories, Inc.
Decision Date1978-08-21
Product CodeKIP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PBS FOR FA (46-991-49) is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K781391. The device is classified under product code KIP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PBS FOR FA (46-991-49)?

PBS FOR FA (46-991-49) is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K781391.

When did PBS FOR FA (46-991-49) receive FDA 510(k) clearance?

PBS FOR FA (46-991-49) received FDA 510(k) clearance on 1978-08-21, under 510(k) number K781391.

Who is the listed applicant for PBS FOR FA (46-991-49)?

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

What is the FDA product code for PBS FOR FA (46-991-49)?

The FDA product code for PBS FOR FA (46-991-49) is KIP.

Other records listing Flow 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.

K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK860762GAMMA-FREE HORSE SERUM

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Related Devices (Code: KIP)

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.

K870484HANKS' BALANCED SALTS (HBSS) NO. H1387Sigma Chemical Co.K870491KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002Sigma Chemical Co.K870486EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509Sigma Chemical Co.K870482(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030Sigma Chemical Co.K860784DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2Tissue Culture InnovationsK844878TRYPSIN 10X - 1:250 IN HBSS W/O CA & MGHazleton Research 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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