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FDA 510(k)

PHOSPHATE BUFFERED SALINE (1X)

K-Number: K811791 · 1981-08-25

ApplicantDutchland Laboratories, Inc.
Decision Date1981-08-25
Product CodeJCC
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PHOSPHATE BUFFERED SALINE (1X) is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-08-25 under 510(k) number K811791. The device is classified under product code JCC. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOSPHATE BUFFERED SALINE (1X)?

PHOSPHATE BUFFERED SALINE (1X) is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K811791.

When did PHOSPHATE BUFFERED SALINE (1X) receive FDA 510(k) clearance?

PHOSPHATE BUFFERED SALINE (1X) received FDA 510(k) clearance on 1981-08-25, under 510(k) number K811791.

Who is the listed applicant for PHOSPHATE BUFFERED SALINE (1X)?

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

What is the FDA product code for PHOSPHATE BUFFERED SALINE (1X)?

The FDA product code for PHOSPHATE BUFFERED SALINE (1X) is JCC.

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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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