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

Viromed Laboratories, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
91 days90th percentile
25clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951461NCI-H292 CELL CULTUREViromed Laboratories, Inc.1996-05-224190
K951440LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTUREViromed Laboratories, Inc.1996-05-224200
K871613BUFFALO GREEN MONKEY KIDNEY CELLSViromed Laboratories, Inc.1987-05-13190
K862555HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)Viromed Laboratories, Inc.1986-07-1070
K861373HUMAN LUNG CARCINOMA CELLS (A549)Viromed Laboratories, Inc.1986-04-1870
K853695RESPIRATORY SYNCYTIAL VIRUS ID REAGENTViromed Laboratories, Inc.1985-12-04910
K852396HEKViromed Laboratories, Inc.1985-07-12360
K852394MDCKViromed Laboratories, Inc.1985-07-12360
K852395MINK LUNGViromed Laboratories, Inc.1985-07-12360
K843252AFRICAN GREEN SV 5/SV 40Viromed Laboratories, Inc.1984-09-06170
K843251RD CELLSViromed Laboratories, Inc.1984-09-06170
K843250BHK-21Viromed Laboratories, Inc.1984-09-06170
K842583SIRCViromed Laboratories, Inc.1984-07-27240
K842584HEKViromed Laboratories, Inc.1984-07-27240
K841806WI-38Viromed Laboratories, Inc.1984-06-07370
K841665RHESUS SV5/SV40Viromed Laboratories, Inc.1984-05-07140
K841666RABBIT KIDNEY CELLSViromed Laboratories, Inc.1984-05-07140
K831686CHLAMYDIA OVERBY MEDIAViromed Laboratories, Inc.1983-07-07440
K831681HEP-2 CELLSViromed Laboratories, Inc.1983-07-06430
K831684CYNOMOLGUS MONKEY KIDNEY CELLS SV5Viromed Laboratories, Inc.1983-07-06430
K831685SF REFEEDING MEDIAViromed Laboratories, Inc.1983-07-06430
K831680VERO CELLSViromed Laboratories, Inc.1983-07-06430
K831682MCCOY CELLSViromed Laboratories, Inc.1983-07-06430
K831683SF CELLSViromed Laboratories, Inc.1983-07-06430
K831679MRC-5 CELLSViromed Laboratories, Inc.1983-07-06430

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