510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Data Medical Associates, Inc.

Mchenry, IL, US

Data Medical Associates, Inc. appears in FDA device records in Mchenry, IL. FDA records list 111 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
111
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 111

FDA records hold 111 510(k) clearances for Data Medical Associates, Inc. between 1978 and 1999. The busiest year on record is 1986, with 50. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Data Medical Associates, Inc., by decision year
YearClearances
19782
19793
19806
19811
19832
19841
198511
198650
19873
19889
19893
19902
19921
19931
19946
19955
19963
19971
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003JIXSubstantially Equivalent
K971113DMA TRIGLYCERIDES PROCEDURESCDTSubstantially Equivalent
K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREJPZSubstantially Equivalent
K955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETJJXSubstantially Equivalent
K955302SERUM BICARBONATE/CARBON DIOXIDEKHSSubstantially Equivalent
K955300TOTAL BILIRUBIN PROCEDURECIGSubstantially Equivalent
K952437DMA GLUCOSE HEXOKINASE U.V. PROCEDURECFRSubstantially Equivalent
K946161DMA TOTAL CHOLESTEROL PROCEDURECHHSubstantially Equivalent
K946354DMA UNSATURATED IRON BINDING CAPACITY PROCEDUREJMOSubstantially Equivalent
K946355DMA ALBUMIN PROCEDURECIXSubstantially Equivalent
K944255DMA CALCIUM PLUS PROCEDURECJYSubstantially Equivalent
K944462DMA IRON PROCEDUREJIYSubstantially Equivalent
K943241DMA GLUCOSE (OXIDASE) PROCEDURECGASubstantially Equivalent
K942424DMA MICROPROTEIN PROCEDURECEKSubstantially Equivalent
K941063DNA TRIGLYCERIDE PROCEDUREJGYSubstantially Equivalent
K940010DMA AMYLASE (DEMAND) PROCEDURECIJSubstantially Equivalent
K931559DMA AMYLASE PROCEDURECIWSubstantially Equivalent
K915803DMA LD KINETIC PROCEDURECFJSubstantially Equivalent
K902202DMA TRIGLYCERIDE (GPO) PROCEDUREJGYSubstantially Equivalent
K895717SODIUM AND POTASSIUM STANDARDJIXSubstantially Equivalent
K895718LITHIUM CONCENTRATE FOR A FLAME PHOTOMETERJGMSubstantially Equivalent
K890868DMA MICROPROTEIN PROCEDURECEKSubstantially Equivalent
K890302CALCIUM PLUS PROCEDURECJYSubstantially Equivalent
K881168CREATINE KINASE (CK) ISOENZYME MBJHTSubstantially Equivalent
K881761UNSATURATED IRON BINDING CAPACITYJMOSubstantially Equivalent
K881326HDL CHOLESTEROL PRECIPITATING PROCEDURELBRSubstantially Equivalent
K881167IRON PROCEDUREJIYSubstantially Equivalent
K881166DIRECT BILIRUBIN PROCEDURECIGSubstantially Equivalent
K880397DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.CIGSubstantially Equivalent
K880396TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.CIGSubstantially Equivalent
K880395TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.CIGSubstantially Equivalent
K874918IRON PROCEDUREJIYSubstantially Equivalent
K872891LACTATE DEHYDROGENASE ISOENZYME 1CEXSubstantially Equivalent
K864825AMYLASE COLORIMETRIC PROCEDUREJFJSubstantially Equivalent
K870062BICARBONATE PROCEDUREKHSSubstantially Equivalent
K863265DIRECT BILIRUBIN PROCEDURECIGSubstantially Equivalent
K863585CHLORIDE PROCEDURECHJSubstantially Equivalent
K863587CREATINE PHOSPHOKINASE(CK) PROCEDURECGSSubstantially Equivalent
K863586GAMMA GLUTAMYL TRANSFERASE PROCEDUREJPZSubstantially Equivalent
K863255LACTATE DEHYDROGENASE(LD) PROCEDURECFJSubstantially Equivalent
K863261CREATININE PROCEDURECGXSubstantially Equivalent
K863588AMYLASE PROCEDUREJFJSubstantially Equivalent
K863268ALKALINE PHOSPHATASE PROCEDURECJESubstantially Equivalent
K863258TOTAL PROTEIN PROCEDURECEKSubstantially Equivalent
K863252CHOLESTEROL PROCEDURECHHSubstantially Equivalent
K863259GLUCOSE HK PROCEDURECFRSubstantially Equivalent
K863257AST/GOT PROCEDURECITSubstantially Equivalent
K863256CALCIUM PROCEDURECICSubstantially Equivalent
K863254TRIGLYCERIDE (TRINDER) PROCEDURECDTSubstantially Equivalent
K863251URIC ACID PROCEDUREKNKSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain