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FDA 510(k)

SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER

K-Number: K850708 · 1985-03-11

ApplicantBausch & Lomb, Inc.
Decision Date1985-03-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 1985-03-11 under 510(k) number K850708. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER?

SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER is a medical device that received FDA 510(k) clearance on 1985-03-11. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K850708.

When did SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER receive FDA 510(k) clearance?

SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER received FDA 510(k) clearance on 1985-03-11, under 510(k) number K850708.

Who is the listed applicant for SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER?

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

What is the FDA product code for SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER?

The FDA product code for SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER is JJQ.

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Other records listing Bausch & Lomb, 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.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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