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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gilford Instrument Laboratories, Inc. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time
90 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823233SBA 300 CLINICAL CHEMISTRY ANALYZERGilford Instrument Laboratories, Inc.1982-11-29310
K821583AMES/GILFORD OPTIMATE CLIN. CHEM & THERGilford Instrument Laboratories, Inc.1982-06-24270
K802609CHEMISTRY ANALYZER IMPACT 400Gilford Instrument Laboratories, Inc.1980-11-26360
K801889MODEL 203S CLINICAL CHEMISTRY ANALYZERGilford Instrument Laboratories, Inc.1980-09-26490
K800085SYSTEM 203 CHEMISTRY ANALYZERGilford Instrument Laboratories, Inc.1980-02-13300
K792361SYSTEM 103 CHEMISTRY ANALYZERGilford Instrument Laboratories, Inc.1979-12-27360
K792087MICROFLAME PHOTOMETERGilford Instrument Laboratories, Inc.1979-11-13270
K791968EIA (ELISA) READERGilford Instrument Laboratories, Inc.1979-10-17160
K790072ANALYZER, IMPACT 200Gilford Instrument Laboratories, Inc.1979-02-22420
K790073ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.1979-02-22420
K781269ELISA SYSTMEGilford Instrument Laboratories, Inc.1978-12-041330
K780888THERMO SET ELECTRONIC TEM. CONTROLLERGilford Instrument Laboratories, Inc.1978-06-28330
K772344DATA ACQUISITION & COLLATING SYS.Gilford Instrument Laboratories, Inc.1978-01-31350
K772319ANALYZER, CLINICAL, SYSTEM 3Gilford Instrument Laboratories, Inc.1978-01-12240
K760749SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALYGilford Instrument Laboratories, Inc.1976-12-29900
K761248ELECTROPHORESIS ACCESSORY MO. 3526Gilford Instrument Laboratories, Inc.1976-12-2180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda