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FDA 510(k)

ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL

K-Number: K882477 · 1988-09-08

ApplicantPasco Laboratories, Inc.
Decision Date1988-09-08
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Pasco Laboratories, Inc.. It received FDA 510(k) clearance on 1988-09-08 under 510(k) number K882477. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL?

ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is Pasco Laboratories, Inc.. The 510(k) number is K882477.

When did ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL receive FDA 510(k) clearance?

ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL received FDA 510(k) clearance on 1988-09-08, under 510(k) number K882477.

Who is the listed applicant for ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL?

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

What is the FDA product code for ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL?

The FDA product code for ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL is JWY.

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Other records listing Pasco Laboratories, Inc. as applicant

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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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