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

Cyberfluor, Inc. — Predicate Candidate Screening

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

62 daysmedian FDA review time
98 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923410FIAGEN PROGESTERONECyberfluor, Inc.1992-12-031460
K905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYCyberfluor, Inc.1991-01-23370
K904539FLAGEN TM FREE T4Cyberfluor, Inc.1990-11-30570
K900621FIAGEN(TM) HLH.SCyberfluor, Inc.1990-03-01210
K895186FIAGEN T3 UPTAKE CATALOGUE #101-402Cyberfluor, Inc.1989-11-08890
K895396CYBERFLUOR FIAGEN TSHCyberfluor, Inc.1989-10-31600
K884708FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.1989-01-17690
K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.1989-01-17690
K884201FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.1988-12-14690
K883182FIAGEN RUBELLA IGGCyberfluor, Inc.1988-10-31950
K882823FIAGEN HGH FLUOROIMMUNOASSAY KITCyberfluor, Inc.1988-08-30530
K882822FIAGEN FERRITINCyberfluor, Inc.1988-08-04270
K874623FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101Cyberfluor, Inc.1988-02-16980
K874624FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301Cyberfluor, Inc.1988-01-11620
K874621FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201Cyberfluor, Inc.1988-01-11620
K874622FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301Cyberfluor, Inc.1987-12-18380
K872803CYBERFLUOR 615 IMMUNOANALYZERCyberfluor, Inc.1987-09-02490

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