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FDA 510(k)

SURESPOT

K-Number: K862701 · 1986-08-19

ApplicantHelena Laboratories
Decision Date1986-08-19
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SURESPOT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862701. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESPOT?

SURESPOT is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Helena Laboratories. The 510(k) number is K862701.

When did SURESPOT receive FDA 510(k) clearance?

SURESPOT received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862701.

Who is the listed applicant for SURESPOT?

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

What is the FDA product code for SURESPOT?

The FDA product code for SURESPOT is JQW.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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