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

Pharmacia, Inc. — Predicate Candidate Screening

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

56 daysmedian FDA review time
174 days90th percentile
129clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974350ALLERGAN IMMUNO CAP M4, M8, K70Pharmacia, Inc.1998-02-09820
K972364UNICAP PHADIATOPPharmacia, Inc.1997-09-04710
K972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82Pharmacia, Inc.1997-07-03300
K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.1997-06-301470
K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHPharmacia, Inc.1997-04-231890
K962274UNICAP 100Pharmacia, Inc.1996-09-12910
K941993PHARMACIA CAP SYSTEM PHADIATOP FEIAPharmacia, Inc.1996-01-306450
K954337GENOTROPIN MIXERPharmacia, Inc.1995-11-13560
K951025PISTON SYRINGEPharmacia, Inc.1995-10-192270
K952025ROBOCAPPharmacia, Inc.1995-07-26860
K911903ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIAPharmacia, Inc.1991-08-121050
K911631PHARMACIA SPECIFIC IGE CONTROLPharmacia, Inc.1991-04-24130
K910517CAP SYSTEM RAST ASM/RIA AND ASM/FEIAPharmacia, Inc.1991-03-05280
K905710PHARMACIA DELFIA NEONATAL HTSH KITPharmacia, Inc.1991-02-21620
K902171MINISPACE(TM) IUI CATHETERPharmacia, Inc.1990-10-051440
K903578PHARMACIA DELFIA SYSTEM B2-MICROPharmacia, Inc.1990-08-1790
K902358MODIFIED DELFIA ESTRADIOL KITPharmacia, Inc.1990-06-18200
K900308SPERM SELECT SYSTEMPharmacia, Inc.1990-04-13810
K900240DELFIA TBG KITPharmacia, Inc.1990-03-30720
K900449PHARMACIA B2 MICRO EIAPharmacia, Inc.1990-02-0560
K894190PHARMACIA CAP SYSTEM RAST RIA & RAST FEIAPharmacia, Inc.1990-01-222200
K895240DELFIA PLATE FLUOROMETER 1232Pharmacia, Inc.1989-10-04440
K894605DELFIA FREE THYROXINE (FT4) KITPharmacia, Inc.1989-09-18600
K893951PHARMACIA CAP SYSTEM IGE RIA AND FEIAPharmacia, Inc.1989-07-14430
K893132PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISCPharmacia, Inc.1989-06-02380
K891135PHADIATOP PAEDIATRIC RIA AND EIAPharmacia, Inc.1989-05-09670
K883814DELFIA HLH SPEC KITPharmacia, Inc.1989-03-081810
K884809DELFIA SHBG KITPharmacia, Inc.1989-03-081110
K890428DELFIA PROGESTERONE KITPharmacia, Inc.1989-02-23280
K880752PHADEBACT SHIGELLA TESTPharmacia, Inc.1989-02-173590
K883559DELFIA THYROXINE (T4) KITPharmacia, Inc.1988-12-141170
K883810DELFIA TRIIODOTHYRONINE (T3) KITPharmacia, Inc.1988-12-02850
K884545DELFIA (TM) HIGE KITPharmacia, Inc.1988-11-10100
K883435NOVASPEC II SPECTROPHOTOMETERPharmacia, Inc.1988-10-13590
K881627DELFIA(TM) NEONATAL HTSH KITPharmacia, Inc.1988-10-031740
K874288PHADEBACT ETEC-LT TESTPharmacia, Inc.1988-09-023180
K882676PHARMACIA CHLAMYDIA EIAPharmacia, Inc.1988-08-29620
K882625PHARMACIA IGE RIA ULTRAPharmacia, Inc.1988-08-08420
K882616ALTERNATE PROCEDURE, PHARMACIA IGE EIAPharmacia, Inc.1988-08-04410
K882626PHARMACIA IGE EIA ULTRAPharmacia, Inc.1988-08-04380
K882173DELFIA ESTRADIOL KITPharmacia, Inc.1988-06-24310
K881892PHARMACIA IGE RIACTPharmacia, Inc.1988-06-10370
K880899PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIAPharmacia, Inc.1988-05-16750
K880719PHARMACIA B2-MICRO RIAPharmacia, Inc.1988-04-21580
K872573PHARMACLUSIVE (TM)Pharmacia, Inc.1988-02-292450
K872572PHARMANET (TM)Pharmacia, Inc.1988-01-141990
K872453DEBRISAN ABSORBENT PADPharmacia, Inc.1988-01-142050
K872946PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCPharmacia, Inc.1987-10-20840
K873077PHARMACIA IGE EIAPharmacia, Inc.1987-10-20760
K873112PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCPharmacia, Inc.1987-10-20710

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