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

Mchenry, IL, US

Granite Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 47 510(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
47
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 47 510(k) clearances for Granite Diagnostics, Inc. between 1977 and 1985. The busiest year on record is 1982, with 28. The most recent is 1985, with 2.

Clearances by year, as a table
510(k) clearance decisions for Granite Diagnostics, Inc., by decision year
YearClearances
19777
19781
19791
19801
19812
198228
19835
19852
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAJSJSubstantially Equivalent
K850969INHIBITORY MOLD AGAR PLATEJSJSubstantially Equivalent
K833254STREPTOCOCCUS ID TRIPLATE SYSTEMJSISubstantially Equivalent
K832365TCBS AGARJSISubstantially Equivalent
K831349STREPTOCOCUS ID PLATEJSTSubstantially Equivalent
K830252DIPCHEX DIP-SLIDE CULTURE SYSJXASubstantially Equivalent
K830251CAMPY BLOOD AGAR PLATEJSISubstantially Equivalent
K823248SCHAEDLER AGARSJSJSubstantially Equivalent
K823139SMITH'S MEDIUMJSJSubstantially Equivalent
K823122LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOMJSISubstantially Equivalent
K822997STREP SELECTIVE AGARJSISubstantially Equivalent
K823001PEPTONE IRON AGARJSFSubstantially Equivalent
K823000MACATE BROTHJSFSubstantially Equivalent
K822999DNASE TEST AGAR W/TOLUIDINE BLUEJSFSubstantially Equivalent
K822998CHRISTENSENS CITRATE SULFIDE AGARJSESubstantially Equivalent
K822996JORDANS TARTRATE AGARJSFSubstantially Equivalent
K822995ANDRADES FERMENTATION MEDIAJSFSubstantially Equivalent
K822994CORN MEAL AGAR W/POLYSORBATE 80JSJSubstantially Equivalent
K823091H BROTHJSHSubstantially Equivalent
K823072LECITHIN LACTOSE AGARJSESubstantially Equivalent
K823071RICE EXTRACT AGARJSHSubstantially Equivalent
K823070ACETAMIDE AGAR SLANTJSHSubstantially Equivalent
K822855YERSINIA ISOLATION MEDIUMJSISubstantially Equivalent
K822702V AGARJSHSubstantially Equivalent
K822694YEAST ASSIMILATION BROTHJSFSubstantially Equivalent
K822527ANAEROBE PEA PLATEJSJSubstantially Equivalent
K822559SXT BLOOD AGARJSJSubstantially Equivalent
K822558LSM AGARJWXSubstantially Equivalent
K822377HAEMOPHILUS ID PLATEJSHSubstantially Equivalent
K822131DERMATOPHYTE TEST MEDIUMJSDSubstantially Equivalent
K821977GRAMSTAIN SETHYISubstantially Equivalent
K821864THIOGLYCOLLATE MED. W/VITAMIN K-1JSCSubstantially Equivalent
K821845EGG YOLK AGAR (PLATE)JSFSubstantially Equivalent
K821775TERGITOL 7 AGAR WITH TTCJSISubstantially Equivalent
K821493LITTMAN OXGAL AGARJSJSubstantially Equivalent
K812451CAMPY THIOGLYCOLLATE (TUBE)JSDSubstantially Equivalent
K810961CAMPYLOBACTER MED. (PLATE)JSJSubstantially Equivalent
K802397ANAEROBE BLOOD AGARJSGSubstantially Equivalent
K790375TRYPTIC SOY AGAR W/ 5% HORSE BLOODJSGSubstantially Equivalent
K780704COLUMBIA AGAR WITH 5% RABBIT BLOODJSISubstantially Equivalent
K771872MARTIN LEWIS TRANSGROWJTYSubstantially Equivalent
K771871MARTIN LEWIS AGAR (PLATE)JTYSubstantially Equivalent
K771870MARTIN LEWIS AGAR (JEMBEC)JTYSubstantially Equivalent
K771661MIDDLEBROOK 7H11 AGAR (PLATE)JSJSubstantially Equivalent
K770874IMPROVED THAYER MARTIN (PLATE)JTYSubstantially Equivalent
K770876IMPROVED TRANSGROWJTYSubstantially Equivalent
K770875IMPROVED THAYER MARTIN (JEMBEC)JTYSubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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