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FDA 510(k)

SERO-STAT R II STAPHYLOCOCCUS TEST

K-Number: K863025 · 1986-09-15

ApplicantScott Laboratories, Inc.
Decision Date1986-09-15
Product CodeLHT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERO-STAT R II STAPHYLOCOCCUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Scott Laboratories, Inc.. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K863025. The device is classified under product code LHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERO-STAT R II STAPHYLOCOCCUS TEST?

SERO-STAT R II STAPHYLOCOCCUS TEST is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Scott Laboratories, Inc.. The 510(k) number is K863025.

When did SERO-STAT R II STAPHYLOCOCCUS TEST receive FDA 510(k) clearance?

SERO-STAT R II STAPHYLOCOCCUS TEST received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863025.

Who is the listed applicant for SERO-STAT R II STAPHYLOCOCCUS TEST?

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

What is the FDA product code for SERO-STAT R II STAPHYLOCOCCUS TEST?

The FDA product code for SERO-STAT R II STAPHYLOCOCCUS TEST is LHT.

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Other records listing Scott 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.

K880694B. CAT CONFIRMK874933MUG-INDOLE DISCK874662MYCO-FLUOR REAGENT A & BK873509IDENTICULT-BLK871238ANABAGK852869SELECTICULT-CHLAMYDIA

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Related Devices (Code: LHT)

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.

K874303STAPHYLASE TESTOxoid U.S.A., Inc.K820683STAPHYLOCOCCUS LATEX AGGLUTINATION KITAmerican Scientific ProductsK820531ENDO-STAPH TEICHOIC ACID ANTIBODY KITMeridian Diagnostics, Inc.K820347ACCU-STAPHCarr-Scarborough Microbiologicals, Inc.K812434DIAGNOSTIC KITS & KIT COMPONENTSDiagnostica, Inc.K812375BABY CHICK BLOOD IN ALSEVER'SDutchland Laboratories, 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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