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FDA 510(k)

NOVASPEC II SPECTROPHOTOMETER

K-Number: K883435 · 1988-10-13

ApplicantPharmacia, Inc.
Decision Date1988-10-13
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVASPEC II SPECTROPHOTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K883435. 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 NOVASPEC II SPECTROPHOTOMETER?

NOVASPEC II SPECTROPHOTOMETER is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Pharmacia, Inc.. The 510(k) number is K883435.

When did NOVASPEC II SPECTROPHOTOMETER receive FDA 510(k) clearance?

NOVASPEC II SPECTROPHOTOMETER received FDA 510(k) clearance on 1988-10-13, under 510(k) number K883435.

Who is the listed applicant for NOVASPEC II SPECTROPHOTOMETER?

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

What is the FDA product code for NOVASPEC II SPECTROPHOTOMETER?

The FDA product code for NOVASPEC II SPECTROPHOTOMETER is JJQ.

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Other records listing Pharmacia, 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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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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